BEUDAMED
    FDA Adverse Event Summary report: N

    PRISMAFLEX

    MDR report key: 3610948 · Received February 6, 2014

    Report

    Report Number
    9616026-2014-00004
    Date Received
    February 6, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 8, 2014
    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 LIKELY ASSOCIATED WITH USE ERROR. UNLOADING OF THE PRISMAFLEX SET DURING AN ONGOING TREATMENT INDICATES THE OPERATOR IGNORED 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). GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY. 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 HAVE NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    THE PRISMAFLEX SET WAS APPARENTLY UNLOADED FROM THE PRISMAFLEX CONTROL UNIT WHILE THE PATIENT WAS STILL CONNECTED TO IT. THE PATIENT BLOOD LINES WERE CLAMPED BUT ONE OF THE FOUR BAGS WAS RED COLORED WITH BLOOD. THE TREATMENT WAS DISCONTINUED WITHOUT RETURNING THE EXTRACORPOREAL BLOOD VOLUME TO THE PATIENT. NO MEDICAL INTERVENTION WAS PROVIDED AND THE PATIENT CONDITION REMAINED UNCHANGED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77724 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 61 YR Other