BEUDAMED
    FDA Adverse Event Death Summary report: N

    1550 HEMODIALYSIS MACHINE

    MDR report key: 383717 · Received March 15, 2002

    Report

    Report Number
    1423500-2002-00350
    Event Type
    Death
    Date Received
    March 15, 2002
    Date of Event
    January 30, 2002
    Report Date
    March 7, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED A PT WAS BEING TREATED ON A 1550 HEMODIALYSIS DEVICE AND THE AIR DETECTION ALARM SOUNDED. THE PT BECAME UNRESPONSIVE AND WAS PLACED IN THE TRENDELENBURG POSITION. THERE WAS NO PULSE, PALPATION, OR REPSIRATION. CPR WAS INITIATED AND PT WAS TRANSPORTED TO THE HOSP WHERE PT EXPIRED. IT WAS REPORTED THAT THE PT WAS IN VERY POOR HEALTH. AIR WAS OBSERVED IN THE BLOODLINES TO THE DRIP CHAMBER. THE CAUSE OF THE INTRODUCTION OF AIR IS UNKNOWN. THE DEVICE SUBSEQUENTLY ALARMED AND THE BLOOD PUMP STOPPED AND THE LINE CLAMPED. ONLY MICROBUBBLES WERE OBSERVED PAST THE LINE CLAMP. IT WAS REPORTED THAT THE SIZE OF THE BUBBLES WERE NOT ANY LARGER THAT WHAT IS NORMALLY OBSERVED. IT WAS REPORTED THAT THE DEVICE PERFORMED PER SPEC AND IS NOT BEING ATTRIBUTED TO THE CAUSE OF DEATH. CAUSE OF DEATH WAS LISTED AS ACUTE MYOCARDIAL INFARCTION. NO MEDICAL TESTS OR AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1550 HEMODIALYSIS MACHINE SPS 1550 FKP BAXTER HEALTHCARE CORP 1550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death DIALYZER WERE USED.| FMC COMBISET BLOODLINES AND A TORUMO T220