BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMBRO

    MDR report key: 2417674 · Received January 11, 2012

    Report

    Report Number
    2417674
    Event Type
    Death
    Date Received
    January 11, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 9, 2012
    Manufacturer
    GAMBRO
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME IT IS UNCLEAR WHETHER THE DEVICE ERRORS ARE RELATED TO THE PATIENT DEATH, BUT BECAUSE WE CANNOT RULE THIS OUT, ARE REPORTING SAME. IN RESPONSE TO SECTION F, THERE WERE TWO DEVICES THAT CONTAINED THE SAME ERRORS. BECAUSE THE MANUFACTURER RETRIEVED THESE DEVICES BEFORE WE COULD COMPLETE REPORTING, WE DO NOT HAVE INFORMATION AS TO WHICH DEVICE WAS BEING UTILIZED AT THE TIME OF THE PATIENT'S DEATH, AND HAVE THUS, INCLUDED SERIAL NUMBERS FOR BOTH.

    Description of Event or Problem · 1

    CONTINUOUS DIALYSIS WAS INITIATED ON (B)(6) 2011. INITIAL SET-UP OF THE GAMBRO PRISMA CRRT MACHINE WAS UNEVENTFUL. DURING THERAPY FROM (B)(6) 2011 THROUGH (B)(6) 2012, THE MACHINE HAD MULTIPLE SELF-TEST FAILURES, BUT WERE RESOLVED WITH HELP THROUGH PHONE CALLS TO TECHNICAL SUPPORT. THE TWO FAILURE CODES WERE 00C0-FILTER AND EFFLUENT POD AND 0040-FILTER PRESSURE POD. AFTER SEVERAL DAYS OF INTERRUPTED THERAPY, A SECOND MACHINE WAS BROUGHT IN, PRIMED, AND THERAPY RESTARTED ON (B)(6) 2012. THE ERROR CODES CONTINUED TO OCCUR AND TECHNICAL SUPPORT CONTINUED TO PROVIDE GUIDANCE, WHICH APPEARED TO RESOLVE THE ERRORS. AT APPROXIMATELY 12:30 ON (B)(6) 2012, THE PATIENT WAS UNRESPONSIVE IN PEA. WE ARE UNABLE TO DETERMINE AT THIS TIME WHETHER THE MACHINE MALFUNCTION CONTRIBUTED TO THE PATIENT'S DEATH, AS THE PATIENT HAD A COMPLEX MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO PRISMA CRRT MACHINE FII GAMBRO PRISMA UNKNOWN
    2 GAMBRO PRISMA CRRT MACHINE FII GAMBRO

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death REPLACEMENT FLUID:| DATE OF TX: (B)(6)| FILTER: DATE OF TX: (B)(6)| DIALYSATE: DATE OF TX: (B)(6)