BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 417260 · Received September 12, 2002

    Report

    Report Number
    1423500-2002-01182
    Event Type
    Death
    Date Received
    September 12, 2002
    Date of Event
    August 1, 2002
    Report Date
    August 14, 2002
    Manufacturer
    ALTHIN MEDICAL, AN AFFILIATE OF BHC
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT COORDINATOR REPORTED MORE ULTRAFILTRATION (UF) WAS REMOVED THEN INTENDED DURING A PATIENT TREATMENT ON A SYSTEM 1000 HEMODIALYSIS MACHINE. ONE HOUR INTO THE TREATMENT, THE PATIENT BECAME SEVERELY HYPOTENSIVE AND WAS CRAMPING. THE TREATMENT CONTINUED FOR TWENTY MORE MINUTES. THE TARGET UF WAS 1.2 KG. THE ACTUAL UF REMOVED WAS 3.3 KG. THE PATIENT WAS ADMINISTERED 1.5 L OF NORMAL SALINE AND TWO CUPS OF TEA IN ORDER TO INCREASE BLOOD PRESSURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS HEMODIALYSIS MACHINE FKP ALTHIN MEDICAL, AN AFFILIATE OF BHC SYSTEM 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN TRICEA DIALYZER AND MIDIAL BLOODLINES.