CareFusion 303 Alaris Pump Module Model 8100 Class I Recall

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CareFusion Alaris Pump Module Model 8100: Class I Recall – Motor Stalls During Infusion

[Posted 08/24/2012]

AUDIENCE: Risk Manager, Biomedical Engineering

ISSUE: FDA notified healthcare professionals and their medical care organizations of the Class 1 recall of this product due to reports of motor stalls during infusion with the Alaris Pump Module, model 8100. Most of the motor stalls reported have occurred at high infusion rates (typically over 900 ml/hr). The firm cannot rule out the possibility of motor stall occurrence at lower infusion rates. When a motor stall occurs, the Alaris PC unit and the Alaris Pump Module display the visual error code 242.4030 with an audible alarm that is followed by a termination of infusion. Termination of infusion, especially in high risk patients, could result in serious injury or death.

BACKGROUND: The Alaris Pump Module, model 8100, is a part used with the Alaris electronic infusion pump system. Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration. It is indicated for use on adults, pediatrics, and neonates.

RECOMMENDATION: On July 20, 2012, CareFusion sent an urgent Medical Device Recall Notification to customers who purchased the Alaris Pump Module, model 8100. Customers were alerted to the potential risk to patient health caused by this failure and the letter advised clinicians to weigh the risk/benefit to patients before continuing to use this device. The following instructions were also communicated to customers:

  • Facilities administering high risk infusions to high risk patients should consider using alternative devices, if available.
  • If alternative devices are not available, facilities should consider having additional devices immediately available as backup.
  • If a motor stall occurs with a pump, facilities should remove the pump module from use and contact the CareFusion Support Center

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 FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm316827.htm

CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall – Potential for Pump Malfunction To Stop Infusion

AUDIENCE: Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I Recall of the CareFusion 303, Alaris Pump Module, Model 8100, due to a potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly. This could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.

BACKGROUND: The pump module is intended for healthcare facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration. The pump module is used for adults, children, and newborns.

RECOMMENDATION: Starting on July 20, 2102, each affected customer and distributor received an URGENT: Medical Device Recall Notification letter, FAQs, Summary of Affected Units and Response Card by overnight courier service. Customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation. (See photo of an example of a separating keypad overlay in link below by locating CareFusion’s URGENT: Medical Device Recall Notification letter. The problem may look different on different pump modules). See a listing of affected serial numbers in the FDA Recall Notice.

Carefusion informed customers that they will contact their facility by phone within 60 days of receiving the letter to schedule a visit to replace the door assembly on their affected pump module.

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 FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm316637.htm

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