BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 908848 · Received September 10, 2007

    Report

    Report Number
    8010182-2007-00009
    Event Type
    Malfunction
    Date Received
    September 10, 2007
    Report Date
    August 10, 2007
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WITH THE FILTER POD OCCURRED DURING THE UNLOADING OF THE PRISMA SET. THE INCIDENT DID NOT RESULT IN ANY INJURY AND, SINCE A PATIENT IS NOT CONNECTED TO THE DEVICE DURING UNLOADING. THERE IS NO RISK OF HARM TO A PATIENT. NO FURTHER ACTION WILL BE TAKEN BY GAMBRO INDUSTRIES. NEVERTHELESS, WE WILL CONTINUE TO MONITOR AND TREND THIS TYPE OF DEFECT TO DETERMINE IF THERE ARE OPPORTUNITIES TO FURTHER REDUCE THE BREAKAGE RATE.

    Description of Event or Problem · 1

    DIALYSIS FILTER WAS BEING UNLOADED ON THE CVVHD MACHINE, BOTTOM POD OF THE FILTER RUPTURED. NO INJURY TO PATIENT OR TO NURSING STAFF. NURSE GOT BLOOD UP HER ARM, BUT NOT ON BROKEN SKIN OR IN EYES. NO SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRISMA M100 PRE SET KDI GAMBRO INDUSTRIES M100 PRE SET UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR