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Device Correction:
Operator’s Manual for Baxter Fenwal Amicus Separator

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DATE NOTIFICATION INITIATED:

    January 25, 2006

PRODUCT / LOT NUMBER:

    Operator’s Manual for Baxter Fenwal Amicus Separator Apheresis Device
    Product Code 4R2332 (All Serial Numbers)

    Amicus Separators Apheresis Devices
    Product Codes 4R4580 and 4R4580R (All Serial Numbers)

MANUFACTURER:

    Baxter Healthcare Corporation
    Largo, Florida

REASON:

    Baxter has become aware of the remote possibility for hemolyzed blood to be returned to the donor after a specific maintenance procedure. Chapter 6 “Maintenance” in the Amicus Operator’s Manual describes a procedure for cleaning the pump head after a blood or fluid spill. To address this issue, Baxter is updating the Amicus Operator’s Manual to remove the maintenance step instructing users to perform the lubrication of the pump head. Instead, qualified Baxter personnel will perform this task during routine servicing and/or preventative maintenance.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

Updated March 2, 2006
 
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