BEUDAMED
    FDA Recall Terminated

    Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

    Recall: Z-0411-06 · Initiated November 7, 2005

    Recall

    Recall Number
    Z-0411-06
    Event Number
    33999
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2005
    Posted
    January 28, 2006
    Terminated
    June 19, 2007
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

    Reason

    Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.

    Action

    Baxter sent Urgent Device Correction letters dated 11/7/05 to the user accounts, advising them of the potential for the circuit boards in the 6060 pump to fail due to a problem that occurred in the supplier's manufacturing process. The letter included a list of 6060 pump serial numbers sent to the user that may contain an affected circuit board. To mitigate safety risks to the patient, Baxter advised customers to immediately discontinue use of the pump for therapies where interruption of the infusion could cause immediate patient harm. In addition, the pump is not to be used if it fails the Power-On Self Test. The accounts were instructed to contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process for the affected 6060 pumps for correction. Baxter sent follow-up letters dated 2/16/06 to the accounts, to the attention of the Director of Biomedical Engineering, informing them that Baxter has sufficient quantities of replacement circuit boards to begin the repairs. The accounts were requested to review the enclosed list of serial numbers for accuracy and telephone Baxter at 1-800-843-7867 to schedule the return of any 6060 Infusion Pump that requires replacement of the circuit board.

    Distribution

    Nationwide, and internationally in France, Germany, Sweden and teh United Kingdom.

    Quantity

    3,141 pumps