BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX FILTER SET

    MDR report key: 1912378 · Received November 16, 2010

    Report

    Report Number
    8010182-2010-00007
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 17, 2010
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMAFLEX M100 FILTER SET WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION. THE LOT NUMBER IS UNK. THERE WAS NO DATA TO REASONABLY SUGGEST THAT ANY GAMBRO PRODUCT MALFUNCTIONED OR MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A POST CARDIAC SURGICAL PATIENT EXPERIENCED RECURRENT CLOTTING OF PRISMAFLEX M100 SET, WHILE RECEIVING A CVVHDF TREATMENT ON PRISMAFLEX MACHINE. THE PATIENT WAS POSSIBLY SEPTIC AND HE WAS NOT RECEIVING ANY ANTICOAGULATION. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS FOLLOWING THE CLOTTING EVENTS, BUT HE RECEIVED A TRANSFUSION OF ONE UNIT OF PACKED RED BLOOD CELLS. THE TREATMENT WAS CONTINUED ON THE SAME PRISMAFLEX MACHINE. ACCORDING TO THE NURSE, ONCE THE CATHETER WAS SWITCHED FROM THE FEMORAL TO THE INTERNAL JUGULAR VEIN, THE FREQUENCY OF THE CLOTTING EVENTS STOPPED. THE PATIENT CONTINUED THERAPY ON THE PRISMAFLEX MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX FILTER SET PRISMAFLEX M100 KDI GAMBRO INDUSTRIES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SWV: 3.20| PRISMAFLEX MACHINE, SN: UNK