—#111240

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K950419
Affected lot / code info: Model 8100; Lot/Serial numbers-various

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.

Timeline

Recall initiated: 2012-06-15
Posted by FDA: 2012-08-17
Terminated: 2014-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.