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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Pump Module Model 8100

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 Class 1 Recall
Alaris Pump Module Model 8100
see related information
Date Posted August 17, 2012
Recall Status1 Terminated on May 13, 2014
Recall Number Z-2205-2012
Recall Event ID 62642
Premarket Notification
510(K) Number
K950419 
Product Classification Pump, Infusion - Product Code FRN
Product Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
Code Information Model 8100; Lot/Serial numbers-various
Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego, California 92121-4386
Manufacturer Reason
for Recall
The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
FDA Determined
Cause 2
DESIGN: Device Design
Action CareFusion sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 20, 2012. The letter identified the product, problem, and actions to be taken by the customers. The potential risk identified in the letter was that when the pump module door keypad overlay has delaminated (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 termination of infusion with alarm. Termination of infusion could result in serious injury or death. Customers were informed that CareFusion will contact their facility with in 60 days of receiving the notification to schedule a visit to replace the door assembly of their affected pump module. Customers with recall related questions were instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports questions were instructed to contact Customer advocacy at (800) 854-7128, option 1, option 1, option 3 or e-mail at customer feedback @carefusion.com. Customers with technical questions were instructed to contact technical support at (888) 812-3229. Customers were instructed to promptly complete and return the enclosed Customer Response Card to expedite the corrective action process.
Quantity in Commerce 43,862 units total (40,780 units in the US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = IMED CORP.
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