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Class I Medical Device Recall: CareFusion 303, Alaris Pump Module, Model 8100

Wed, 08/22/2012 - 12:00am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: June 15, 2012

Product: CareFusion 303, Alaris Pump Module, Model 8100 (formerly Medley Pump Module)

Serial Numbers: Refer to CareFusion’s recall webpage under Additional Links below.

Door assembly with keypad part number TC10005926

Manufacturing Dates: The affected pump modules were manufactured from October, 2011 through February, 2012.

Use: 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.

Recalling Firm:
CareFusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego, California 92121-4386

Reason for Recall: There is a potential risk that the pump module door keypad overlay may separate from the keypad assembly. This product may cause serious adverse health consequences, including death.

Public Contact: See contact information below.

FDA District: Los Angeles

FDA Comments:

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 delivered upon signed receipt

The Recall Notification letter identified the problem and the action to be taken.

The firm identified the potential problem when the pump module door keypad overlay was loose, peeled away, or separated 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, it could result in serious injury or death.

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).

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.

Customers with recall-related questions were instructed to contact Carefusion Support Center at 1-888-562-6018. Customers with questions about adverse event reports were instructed to contact Customer Advocacy at 1-800-854-7128, option 1, option1, option 3, or email customerfeedback@carefusion.com (24 hours a day, 7 days a week).

Customers with technical questions were instructed to contact technical support at 1-888-812-3229 (7 am to 5pm, Pacific Time).

Customers were instructed to promptly complete and return the enclosed customer response card to expedite the corrective action process.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links:

 

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