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Alaris Pump Module Model 8100 (formerly Medley Pump Module) recallZ-2205-2012 · CareFusion 303, Inc. · initiated Jun 15, 2012

Class I Terminated All recalls posted in August 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2205-2012
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jun 15, 2012
Posted by the FDA
Aug 17, 2012
Recalling firm
CareFusion 303, Inc.
Quantity
43,862 units total (40,780 units in the US)
Product code
FRN
FDA submissions
K950419
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.

Product description

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 (models, lots, serial numbers)

Model 8100; Lot/Serial numbers-various

Other devices under the same FDA submission

1 device cleared under K950419 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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