BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 537691 · Received August 5, 2004

    Report

    Report Number
    9616240-2004-00012
    Event Type
    Other
    Date Received
    August 5, 2004
    Date of Event
    September 1, 2003
    Report Date
    May 3, 2004
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SUMMARY OF INVESTIGATION: SAFETY AND PERFORMANCE TESTS WERE MADE: IN 2003, IT WAS SIMULATED USE: DIALYSIS UNIT PASSED TESTS PER MFR'S SPECIFICATIONS, INCLUDING REMOVING THE CORRECT AMOUNT OF FLUID OVER TIME. THEY WERE ABLE TO REPRODUCE EVENT IF FLOW OF DIALYSATE FROM TUBING WAS NOT CONNECTED TO BAG PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS FII GAMBRO DASCO PRISMA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other