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