BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMA

    MDR report key: 735950 · Received July 18, 2006

    Report

    Report Number
    8010182-2006-00009
    Event Type
    Death
    Date Received
    July 18, 2006
    Date of Event
    July 5, 2006
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ABSENCE OF INCRIMINATED SAMPLE FOR INVESTIGATION; ABSENCE OF FURTHER INFORMATION FROM THE CLINIC INVOLVED; INCIDENT STIL UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE ESTABLISHED AND FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    POSSIBLE HEMOLYSIS - GRP REP CALLED TO REPORT BLOOD IN THE EFFLUENT LINE. MACHINE DID NOT ALARM, BUT EFFLUENT LINE TURNED PINK. THE FIRST TWO SETS OCCURRED BEFORE 8:19 THE THIRD SET AT 10:32. NURSE TRIED 3 DIFFERENT LOT NUMBERS (UNKNOWN AT THIS TIME) ON 2 DIFFERENT MACHINES (2ND S/N# UNKNOWN AT THIS TIME) AND THE EFFLUENT LINE TURNED PINK. REP RECOMMENDED THE NURSES TO CONTACT PHYSICIAN BEFORE CONTINUING TREATMENT, BUT DURING THAT TIME, PATIENT'S FAMILY DECIDED T WITHDRAW CARE AND PATIENT EXPIRED. NURSE DID NOT BELIEVE THE SETS FOR THE MACHINES CONTRIBUTED TO PATIENT'S DEATH. NURSE SAID PATIENT HEALTH ALREADY HAD CLINICAL CONDITION. PATIENT HAD A TRIPLE 8 REPAIRS AND ACUTE RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRISMA M100 PRE SET FJK GAMBRO INDUSTRIES M100 05L2078G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death