http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351525.htm

The Compounding Shop: FDA News Release – Lack of Sterility Assurance of Drug Products

AUDIENCE: Pharmacy, Healthcare Professionals, Patients

ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.

The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.

BACKGROUND:  The FDA is basing this warning on a recent inspection of The Compounding Shop. The investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop’s sterile drug products.

RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products. Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the complete MedWatch Safety Alert, including a link to the News Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351326.htm

Maquet SERVO-i Ventilator Battery Module: Class 1 Recall – Battery Run Time Shorter Than Expected

AUDIENCE: Anesthesiology, Biomedical Engineering, Nursing, Risk Managers

ISSUE:  Some battery modules distributed after Jan. 31, 2010 have a shorter battery run time than expected. This can result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. This recall covers 90,000 battery modules distributed in the United States between 02/15/2010 and 11/19/2012.

BACKGROUND: Battery modules allow device users a possibility to operate the SERVO-i ventilator during intra-hospital transportation. The SERVO-i system is used to treat and monitor patients ranging from neonates to adults with respiratory failure or insufficiency.

RECOMMENDATION:  Customers are instructed to change the power source to AC and replace the battery modules if either “low battery voltage” or “replace battery” messages are displayed. Customers are instructed to complete and return a Field Safety Notice Confirmation Form by email to FieldAction@maquet.com or via fax at (973) 807-1832.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351146.htm

Medtronic: Class 1 Recall – Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit

AUDIENCE: Neurology, Nursing, Risk Manager, Surgery

ISSUE: Medtronic sent an Urgent Medical Device Correction letter to all affected customers notifying them of the potential for damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. If this happens, the damage would most likely occur at lead contact #3 which could affect electrode contact #3.Depending on the extent of lead damage and the need to use electrode #3, lead replacement may be required or optimal therapy may not be provided.

This recall covers 1,598 devices distributed in the United States between 04/2006 and 02/28/2013. Refer to the Recall Notice for a list of affected models. 

BACKGROUND: The deep brain stimulation (DBS) system delivers electrical stimulation to selected targets in the brain. DBS leads are indicated for Dystonia, Essential Tremor, Obsessive-Compulsive Disorder, Parkinson’s disease, and epilepsy. Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus or the subthalamic nucleus to aid in the management of chronic, intractable (drug refractory) primary dystonia including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis).

RECOMMENDATION: If the lead cap is used during the implant procedure, customers should follow modified instructions (refer to the Urgent Medical Device Correction letter for details). For questions call Medtronic Neuromodulation Technical Services 1-800-707-0933. The firm is providing additional instructions for capping the lead and removing the lead cap and is not removing the product from market. There is no action required for existing patients in the absence of concern over potential lead damage.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351094.htm

Cardinal Health: Class 1 Recall – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit

AUDIENCE: Anesthesiology, Biomedical Engineering, Risk Manager, Surgery

ISSUE: Cardinal Health discovered that various Presource Kits containing a pre-assembled anesthesia circuit and filter may contain outer plastic packaging on one or more components. If the packaging is removed without dissembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction in airflow. This may result in serious adverse health consequences including low blood oxygen (hypoxia), suffocation and death.

BACKGROUND: Cardinal Health’s pre-assembled Filter and Anesthesia Circuit are intended to provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to a patient. These assemblies are included in various Presource convenience kits including, but not limited to, gynecology laparoscopy kits, general laparoscopy kits, knee arthroscopy kits, and total hip kits.

RECOMMENDATION: Cardinal Health notified customers of the problem and products affected (refer to the Recall Notice for a full list of affected products). Customers should examine their inventories, identify and locate the products affected, notify clinicians, and affix a WARNING LABEL on the front of each kit. The WARNING LABEL instructs clinicians to remove and discard the anesthesia circuit and filter assembly. Customers are also asked to confirm receipt of the notification letter and completion of the labeling activity by returning an Acknowledgement Form. If customers are not comfortable with adding the WARNING LABEL to the kits or using these kits, they should contact Cardinal Health at 1-800-766-0706 for further instructions.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351024.htm

Valproate Anti-Seizure Products: Drug Safety Communication – Contraindicated for Pregnant Women for Prevention of Migraine Headaches

Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics

AUDIENCE: Health Professional, Neurology, Pharmacy, Patient

ISSUE: FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from “D” (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to “X” (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).

Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.

BACKGROUND: Valproate products are approved for the treatment of certain types of epilepsy, the treatment of manic episodes associated with bipolar disorder, and the prevention of migraine headaches. They are also used off-label (for uses not approved by FDA) for other conditions, particularly other psychiatric conditions.

This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. For additional details, see the Drug Safety Communication Data Summary section.

RECOMMENDATION: Valproate products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable. 

Women who are pregnant and taking a valproate medication should not stop their medication but should talk to their health care professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350868.htm

Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication – Potential Medication Errors Resulting from Name Confusion

AUDIENCE: Risk Manager, Pharmacy, Oncology

ISSUE: The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products could lead to dosing errors and potential harm to patients.

The FDA-approved nonproprietary name for Kadcyla, ado-trastuzumab emtansine, should be used. However, some third-party publications, compendia references, health information systems (e.g., electronic health record systems and systems used for pharmacy prescription processing, wholesaler ordering, pharmacy ordering, etc.), and sites on the Internet are incorrectly using the United States Adopted Name (USAN), which is “trastuzumab emtansine,” and omitting the “ado” prefix and hyphen. Use of this truncated version of Kadcyla’s nonproprietary name may cause confusion with Herceptin (trastuzumab).

It is important for drug information content publishers to identify drug products by the FDA-approved proprietary (brand) and nonproprietary names that are used in FDA-approved drug labels. This will help prevent medication errors and ensure adverse events are reported for the correct product.

No medication errors related to confusion between Kadcyla and Herceptin have been reported to FDA since approval of Kadcyla on February 22, 2013; however medication errors did occur during the clinical trials that evaluated its safety and efficacy prior to approval.

BACKGROUND: Kadcyla is used to treat HER2-positive breast cancer that has spread to other parts of the body in patients who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Kadcyla is made up of trastuzumab, an anti-HER2 therapy, connected to a drug called DM1 that interferes with cancer cell growth.

RECOMMENDATION: Health care professionals should use both the FDA-approved proprietary (brand) name Kadcyla and its nonproprietary name (ado-trastuzumab emtansine) when communicating medication orders, on preprinted order sets, and in computerized order entry systems. Such redundancy may help to reduce the potential for medication errors. Additionally, strategies should be employed to warn against confusion between Kadcyla (ado-trastuzumab emtansine) and Herceptin (trastuzumab) in medication-related computer systems.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350817.htm

Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall – Unit Goes Into Internal Backup Battery Sooner Than Expected

AUDIENCE: Risk Manager, Nursing

ISSUE: The recall is in response to customer reports of Newport Medical Instrument’s HT70 Ventilator and HT70 Plus Ventilator alarming and going into internal backup battery sooner than expected, while the ventilator is being operated on Power Pac battery. Serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F These ventilators were manufactured from Nov. 1, 2009 to March 5, 2013 and distributed from Oct. 1, 2011 to Jan. 31, 2013.

These conditions have been reported in two types of situations. In the first situation, the screen on the Newport Medical Instrument’s HT70 Ventilator or HT70 Plus Ventilator may indicate that the Power Pac battery is fully charged when it is not. In the second situation, the unit may switch to backup battery power as soon as it is removed from AC power.

Use of this device on battery power may cause serious adverse health consequences, including death.

BACKGROUND: The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation.

Newport Medical Instruments, Inc. is a wholly-owned subsidiary of Covidien.

RECOMMENDATION: On April 4, 2013, Newport Medical Instruments sent an Urgent Medical Device Recall letter by FedEx to all its affected customers. The letter identified the product, the problem, and the action to be taken by the customer.

Anyone who has Power Pac batteries for the Newport Medical Instrument’s HT70 and HT70 Plus ventilators, including distributors, health care providers, and home users, is instructed to immediately check the serial numbers of the Power Pac batteries related to their Newport HT70 and HT70 Plus ventilators. Customers whose Power Pac serial numbers fall within the above range should contact Newport Medical Instrument’s Technical Support Department to request replacement batteries, which will be provided at no charge.

If customers are using the affected product, they should ensure that an alternate source of power is available nearby until this issue is resolved. Customers were also instructed to report any issues with Newport Medical Instrument’s HT70 and HT70 Plus ventilators or Power Pac batteries to the Technical Support group at 1-800-451-3111, extension 500 to ensure proper device reporting procedures are followed.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350438.htm

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall – Labeling Issue Identified

Read the MedWatch Safety Alert, including links to the Recall at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350275.htm

AUDIENCE: Risk Manager, Health Professional, Pharmacy

ISSUE: Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM13A15027) of product code 4R1584, Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK unit.  Fenwal identified a labeling issue with this batch of Product Code 4R1584 in which the platelet container is incorrectly labeled as “AS-1 Red Blood Cell Adenine-Saline added”.

BACKGROUND: To date, there is only one reported occurrence of this incident and no safety concerns have been raised.

RECOMMENDATION: Fenwal is recommending that customers immediately check their inventory, discontinue the use of this product, and return the impacted product to Fenwal.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178