BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMP 80/2 PERITONEAL DIALYSIS SYSTEM

    MDR report key: 112162 · Received August 7, 1997

    Report

    Report Number
    2937457-1997-00048
    Event Type
    Death
    Date Received
    August 7, 1997
    Date of Event
    April 7, 1997
    Report Date
    April 7, 1997
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERITONEAL DIALYSIS ON A CYCLER WAS INITIATED ON A PT IN THE HOSP AT 3:45 PM. THE PRESCRIPTION WAS FOR 5 EXCHANGES, FILL VOLUME OF 2 LITERS, FILL/DWELL TIME OF 2 HRS AND DRAIN TIME OF 15 MINUTES. THE NURSE OBSERVED THE FIRST FILL AND FELT THAT EVERYTHING WAS FINE. THE NURSING ASSISTANTS OBSERVED THE PT AT 5:15 PM AND 5:55 PM AND FELT THAT EVERYTHING WAS FINE. THE PT WAS FOUND DEAD AT 6:15 PM. THE PERITONEAL DIALYSIS NURSE ON CALL OBSERVED UPON HER ARRIVAL THAT THE CYCLER WAS TURNED OFF AND THE PT LINE WAS CLAMPED. ALL (5) OF THE 2 LITER BAGS WERE EMPTY AND THERE WAS 6.4 LITER OF EFFLUENT IN THE DRAIN BAG. APPROXIMATELY 5 LITERS OF SOLUTION WAS DRAINED FROM THE PT AFTER A COUPLE OF HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMP 80/2 PERITONEAL DIALYSIS SYSTEM PERITONEAL DIALYSIS CYCLER KPF FRESENIUS MEDICAL CARE NORTH AMERICA 80/2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death