BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMAFLEX

    MDR report key: 3549764 · Received January 3, 2014

    Report

    Report Number
    9616026-2014-00001
    Event Type
    Death
    Date Received
    January 3, 2014
    Date of Event
    November 11, 2013
    Report Date
    December 5, 2013
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K110823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS MOST LIKLEY ASSOCIATED WITH USE ERROR. THE OPERATOR REMOVED THE PRISMAFLEX SET PRIOR TO ENDING THE TREATMENT, CLAMPING THE LINES AND DISCONNECTING THE PATIENT. THIS COULD ONLY HAPPEN IF THE OPERATOR NEGLECTS THE WARNINGS ON THE PRISMAFLEX SCREEN. BEFORE THE SET IS UNLOADED, A WARNING APPEARS ON THE SCREEN STATING ALL LINES MUST BE CLAMPED BEFORE UNLOADING THE SET. THE OPERATOR IS THEN INSTRUCTED TO PRESS THE UNLOAD SOFT KEY TO CONFIRM THAT THE PATIENT IS DISCONNECTED IN ORDER TO PROCEED WITH THE UNLOADING OF THE SET. THIS WARNING IS ALSO PROVIDED IN THE PRISMAFLEX OPERATOR¿S MANUAL. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRISMAFLEX CONTROL UNIT WITH SW 6.10 INVOLVED IN THIS EVENT DOES NOT HAVE 510 (K) CLEARANCE BUT IS SIMILAR TO PRISMAFLEX CONTROL UNIT SW 5.10 (510(K) CLEARANCE K110823). THERE IS NO INFORMATION INDICATING THAT THE PRISMAFLEX CONTROL UNIT HAS BEEN INSPECTED BY A GAMBRO TECHNICIAN (OR ANY OTHER TECHNICIAN). THE TREATMENT DATA CARD FILES FROM THE PRISMAFLEX CONTROL UNIT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    A PATIENT UNDERGOING A CRRT TREATMENT ON A PRISMAFLEX CONTROL UNIT HAD A BLOOD LOSS WHEN THE EXTRACORPOREAL CIRCUIT WAS UNLOADED WITHOUT ENDING TREATMENT AND CLAMPING THE BLOOD LINES. THE PATIENT WAS TRANSFUSED WITH A UNIT OF BLOOD. FOLLOWING THE BLOOD TRANSFUSION, THE PATIENT BECAME HYPOTENSIVE, WENT ASYSTOLE AND WAS SUCCESSFULLY RESUSCITATED. TWO HOURS LATER, THE PATIENT EXPERIENCED ANOTHER CARDIAC ARREST AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3892 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO LUNDIA AB 114489 (SW 6.10) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death