BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX TPE

    MDR report key: 3132268 · Received May 29, 2013

    Report

    Report Number
    8010182-2013-00006
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    LKN
    PMA / PMN Number
    P830063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILTER SET WAS DISCARDED AND THEREFORE, NOT AVAILABLE FOR INSPECTION. THE REVIEW OF THE DEVICE HISTORY RECORD OF THE LOT NUMBER OF THE TPE FILTER SETS AND THE COMPLAINT HISTORY FILES HAS SHOWN THAT THERE WERE NO NONCONFORMITIES AND NO SIMILAR COMPLAINT REPORTED ON THESE LOT NUMBERS. GAMBRO RECEIVED NO INFORMATION TO SUGGEST THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT AND IT DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A PATIENT DIAGNOSED WITH WEGENER'S GRANULOMATOSIS, A RARE CONDITION THAT RESULTS IN BLOOD DISORDERS, IS REPORTED TO HAVE UNDERGONE FOUR THERAPEUTIC PLASMA EXCHANGE (TPE) TREATMENTS. ALL FOUR TREATMENTS WERE ASSOCIATED WITH MORE THAN 1 EPISODE OF THE CLOTTING OF THE TPE FILTER SET. THERE WERE APPROXIMATELY TWELVE TPE FILTER SETS USED ON THIS PATIENT DURING AN UNDISCLOSED PERIOD OF TIME. THE BLOOD WAS APPARENTLY NOT RETURNED FOLLOWING ALL OF THE EVENTS AND IT IS LIKELY THE PATIENT HAD A CUMULATIVE BLOOD LOSS OF 500 ML HOWEVER, THIS HAS NOT BEEN CONFIRMED. THE PATIENT REPORTEDLY WAS TRANSFUSED WITH BLOOD SOMETIME DURING THE TPE TREATMENTS. NO ADDITIONAL MEDICAL OR CLINICAL INFORMATION HAS BEEN PROVIDED DESPITE GAMBRO¿S REQUEST FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236023 PRISMAFLEX TPE LKN GAMBRO INDUSTRIES 107144 12D1303 - 12D2604 - 13B1305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRISMAFLEX, SN NOT PROVIDED