BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMA

    MDR report key: 938799 · Received November 8, 2007

    Report

    Report Number
    8010182-2007-00012
    Event Type
    Injury
    Date Received
    November 8, 2007
    Date of Event
    August 10, 2007
    Report Date
    September 10, 2007
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE REVIEW OF GAMBRO'S COMPLAINT FILE INDICATED THAT THIS WAS THE SECOND OCCASION WHEN SUCH AN EVENT WAS REPORTED ON NEW DESIGN OF THE PRISMA PRE SET. IN THE ABSENCE OF THE SAMPLE, THE LOT NUMBER, AND THERAPY USED DURING THE TREATMENT. GAMBRO HAS NOT FOUND ANY EVIDENCE TO SUGGEST THE DEVICE WAS INCLUDED ON THE SERIOUS INJURY REPORTED. GAMBRO DOES NOT REGARD SUBMITTAL OF THIS REPORT AS AN ADMISSION OF RESPONSIBILITY FOR THE INCIDENT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL IN THE MORNING OF THE 2007 WITH A URINARY TRACT INFECTION, DIARRHOEA AND VOMITING. THE PATIENT HAD TAKEN ACE INHIBITORS TO TREAT HER BLOOD PRESSURE PREVIOUSLY. CONTINUOUS RENAL REPLACEMENT THERAPY WAS INITIATED. THE PATIENT HAD SUFFERED A SIGNIFICANT DECREASE IN BLOOD PRESSURE WHEN CONNECTED TO THE PRIMSA MACHINE ON THE SUCCESSIVE OCCASIONS. ON THE FIRST OCCASION THE PATIENT REQUIRED FLUID SUPPORT AND RESUSCITATION. ON THE SECOND OCCASION, THE PATIENT REQUIRED 2 MINUTES OF CPR. ON THE THIRD OCCASION THE PATIENT HAD INCREASED IONOTROPIC SUPPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization