BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 968754 · Received November 14, 2007

    Report

    Report Number
    2087532-2007-00217
    Event Type
    Other
    Date Received
    November 14, 2007
    Date of Event
    September 5, 2007
    Report Date
    October 16, 2007
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GAMBRO RECEIVED MEDWATCH FORM 3933020000-2007-8010 (ATTACHED) ON OCTOBER 16, 2007, REPORTING AN INCIDENT WITH THE BLOODLINES ON A PRISMA MACHIEN WHILE A PT WAS UNDERGOING CVVHD TREATMENT. IN RESPONSE, THE TREATING NURSE DISCONTINUED THE TREATMENT WITHOUT RETURNING BLOOD TO THE PT, RESULTING IN A BLOOD LOSS OF 107ML. EVAL BY BIOMED COULD NOT REPRODUCE THE PROBLEM-ALTHOUGH ORIGINAL TUBING/SET UP HAD BEEN REMOVED. FOR BIOMED PERSONNEL, BLOOD PUMP LOADED AND UNLOADED NORMALLY, ALL PRESSURES AND SOLENOIDS WERE VERIFIED ALONG WITH ALL SCALES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other