BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMP 80/2 PERITONEAL DIALYSIS SYSTEM

    MDR report key: 147622 · Received February 8, 1998

    Report

    Report Number
    2937457-1998-00008
    Event Type
    Death
    Date Received
    February 8, 1998
    Date of Event
    December 24, 1997
    Report Date
    January 14, 1998
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MFR REC'D A REPORT FROM A DISTRIBUTOR OF PERITONEAL DEVICE REGARDING A FATAL INCIDENT INVOLVING A PT WHO SUFFERED A LARGE FLUID OVERLOAD EARLY INTO A PERITONEAL DIALYSIS TREATMENT. CAUSE OF DEATH REPORTED WAS CARDIOVASCULAR COLLAPSE SECONDARY TO ABDOMINAL OVERFILLING. THE DEVICE WAS RECOVERED AND EXAMINED AND IT WAS CLEARLY EVIDENT THAT THE MACHINE HAD BEEN SET UP INCORRECTLY.

    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 78 YR Death