BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 1517032 · Received October 16, 2009

    Report

    Report Number
    3004548776-2009-00002
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 17, 2009
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    PMA / PMN Number
    BK960005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DATA FROM THE AMICUS INSTRUMENT ON (B)(6) 2009, INDICATED THAT ACD PUMP SUCCESSFULLY PASSED ALL FUNCTIONAL CHECKS DURING PRIME. UPON VISUAL INSPECTION OF THE UPPER HOUSING OF THE PUMP, IT WAS OBSERVED THAT THE RETAINING WASHER TYING THE INTERMEDIATE GEAR TO THE PINION GEAR WAS MISALIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE DONOR WAS DONATING PLATELETS ON THE AMICUS SEPARATOR. DURING THE PROCEDURE, THE OPERATOR REPORTED AIR PURGE ALARMS. THE NUMBER OF AIR PURGE ALARMS WERE NOT DOCUMENTED. THE OPERATOR WAS NOT ABLE TO PROCEED WITH THE PROCEDURE AFTER 57 MINUTES AND 2845 ML OF BLOOD HAD BEEN PROCESSED. WHEN REMOVING THE NEEDLE FROM THE DONOR, A FIBRIN CLOT WAS NOTED ON THE END OF THE NEEDLE. A VISUAL INSPECTION OF THE ACD BAG INDICATED THAT APPROX 45ML OF ACD HAD BEEN DELIVERED AT THE END OF THE PROCEDURE. THE INSTRUMENT SCREEN ALSO CONFIRMED THAT ONLY 45ML OF ACD HAD BEEN USED, WHICH IS THE AMOUNT OF ACD NEEDED FOR PRIME OF THE KIT, INDICATING THAT ACD WAS NOT DELIVERED DURING THE DONATION. VITAL SIGNS WERE NOT AVAILABLE FROM THE CENTER. THE DONOR WAS HELD AT THE CENTER FOR 30 MINUTES AND WAS DISCHARGED "IN GOOD CONDITION." NO FOLLOW UP CALLS WERE MADE BY THE CENTER THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICUS SEPARATOR SYSTEM AUTOMATED BLOOD CELL SEPARATOR GKT FENWAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 AMICUS DOUBLE NEEDLE KIT: CODE AND LOT NUMBER NOT| PROVIDED,| MANUFACTURED BY FENWAL, INC.