BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 275787 · Received April 27, 2000

    Report

    Report Number
    2937457-2000-00025
    Event Type
    Death
    Date Received
    April 27, 2000
    Report Date
    March 30, 2000
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMODIALYSIS TREATMENT IN A NURSING HOME, THE NURSE NOTICED THAT THE VENOUS LINE HAD SEPARATED FROM THE PT'S CATHETER. THERE WAS NO MACHINE ALARM. IT WAS REPORTED THAT THE TRANSDUCER PROTECTOR WAS WET WITH BLOOD WHICH COULD HAVE RESULTED IN INACCURATE VENOUS PRESSURE READING. THE ESTIMATED BLOOD LOSS WAS ONE LITER. THE PT WAS ADMITTED TO THE HOSP AND LATER EXPIRED. THE PHYSICIAN BELIEVED THAT THE BLOOD LOSS CONTRIBUTED TO THE DEATH, BUT WAS NOT THE PRIMARY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL CARE-NORTH AMERICA 2008E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H