BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPHERESIS C PLASMAPHERESIS INSTRUMENT, A200

    MDR report key: 632368 · Received September 2, 2005

    Report

    Report Number
    1420141-2005-00044
    Event Type
    Injury
    Date Received
    September 2, 2005
    Date of Event
    June 18, 2005
    Report Date
    August 5, 2005
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REGULAR PLASMAPHERESIS DONOR CAME TO THE PLASMA DONATION CENTER IN 08/2005. WHEN THE CENTER STAFF ASKED ABOUT A CAST ON THEIR LEFT FOOT THE DONOR EXPLAINED THAT AFTER THEIR LAST DONATION IN ABOUT SIX WEEKS EARLIER DONOR HAD PASSED OUT WHILE DRIVING AND WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT. DONOR SUSTAINED MULTIPLE FRACTURES IN THEIR LEFT FOOT. THEIR REPORT INDICATED DONOR WAS TRANSFERRED VIA AMBULANCE FROM THE ACCIDENT SITE AND WAS ADMITTED TO THE HOSP WHERE DONOR HAD SURGERY TO REPAIR MULTIPLE FRACTURES IN THEIR LEFT FOOT. DONOR STATED THEY WERE IN THE HOSP FOR THREE DAYS AND RECEIVED IV ANTIBIOTICS. WHEN DONOR WENT HOME DONOR HAD A POST-OP INFECTION AT THE INCISION SITE AND REQUIRED AN ADDITIONAL COURSE OF ANTIBIOTICS. DONOR INDICATED FEELING FINE AND HEALTHY IN 08/2005 BUT THEIR FOOT WAS SWOLLEN AND DONOR WILL NEED TO WEAR A BOOT UNTIL THE SWELLING SUBSIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPHERESIS C PLASMAPHERESIS INSTRUMENT, A200 AUTOPHERESIS-C HARDWARE GKT BAXTER HEALTHCARE CORP. 4R4550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization