BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEGLYCE/CELL WASH SET, 275 ML

    MDR report key: 6241735 · Received January 11, 2017

    Report

    Report Number
    1219343-2017-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 2, 2016
    Report Date
    December 13, 2016
    Manufacturer
    HAEMONETICS CORP
    Product Code
    KSW
    PMA / PMN Number
    BK060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BAG SAMPLE WAS RETURNED TO HAEMONETICS FOR EVALUATION. THE EVALUATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SENT ONCE THE EVALUATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A REPORT FROM A CUSTOMER ON 12/13/2016 STATING THAT A PLANNED INTRA-UTERINE TRANSFUSION HAD TO BE CANCELED DUE TO TWO RED CELL BAGS LEAKING AFTER CENTRIFUGATION. THESE RED CELL BAGS HAD BEEN DE-GLYCEROLIZED UTILIZING THE HAEMONETICS® ACP®215 DEVICE . THE CUSTOMER THEN TOOK THE BAG AND CENTRIFUGED IT IN ORDER TO CONCENTRATE THE RBCS TO A HEMATOCRIT OF 0,70-0,85. THE CENTRIFUGATION OF THE BAGS IS NOT A STEP IN THE DE-GLYCEROLIZATION PROCESS THAT HAEMONETICS OUTLINES IN THE ACP®215 OPERATOR'S MANUAL. THE CUSTOMER STATED THAT THE LEAKS WERE NOT OBSERVED UNTIL AFTER THEY HAD CENTRIFUGED THE BAGS. THE INTRA-UTERINE TRANSFUSION WAS REQUIRED AS THE MOTHER HAS AN ALLOIMMUNIZATION TO ERYTHROCYTE ANTIGENS WHICH IS PASSED OVER THE PLACENTA AND MAY CAUSE ANEMIA IN THE FETUS. THE TWO BEST MATCHED ERYTHROCYTE UNITS WERE CONTAINED IN THE TWO BAGS THAT LEAKED DELAYING THE TRANSFUSION TO THE FETUS, SO THE GYNECOLOGIST DECIDED TO POSTPONE THE TRANSFUSION BECAUSE THERE WERE NO OTHER COMPLETELY MATCHED UNITS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24750 DEGLYCE/CELL WASH SET, 275 ML DEGLYCE/CELL WASH SET, 275 ML KSW HAEMONETICS CORP 00235-00 0116063

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization