BEUDAMED
    FDA Adverse Event Death Summary report: N

    80/2

    MDR report key: 258834 · Received January 12, 2000

    Report

    Report Number
    2937457-2000-00003
    Event Type
    Death
    Date Received
    January 12, 2000
    Date of Event
    October 13, 1999
    Report Date
    November 16, 1999
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    KPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A LAWYER REPRESENTING THE HOSP REPORTED THAT PT HAD A RESPIRATORY ARREST DURING A "CCPD" TREATMENT AND EXPIRED ABOUT A WEEK LATER. THERE WERE NO MACHINE PROBLEMS REPORTED, BUT IT WAS OBSERVED THAT THERE WAS 1,000 ML. OF SOLUTION IN THE HEATER CABINET, 3,600 ML. IN THE DRAIN BAG AND NO SOLUTION LEFT IN THE SOURCE BAGS. THE PT WAS DRAINED MANUALLY AND 2,850 ML. OFSOLUTION WAS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death