CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction To
Thursday, August 23, 2012
CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction To Stop Infusion
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.
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.
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
the MedWatch safety alert, including a link to the FDA Recall Notice HERE.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 8/23/2012)