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

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.