BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLOOD MONITOR PUMP

    MDR report key: 384303 · Received March 19, 2002

    Report

    Report Number
    384303
    Event Type
    Death
    Date Received
    March 19, 2002
    Date of Event
    March 1, 2002
    Report Date
    March 14, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FIR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED IN 2002 FOR ALTERED MENTAL STATUS AND HYPOTENSION. K+ 2.9 ON ADMISSION. NEW ONSET CYANOSIS TOES LEFT FOOT. MD ORDERED HEMOFILTRATION DUE TO PT'S CONDITION. HEMOFILTRATION UNIT ARTERIAL PRESSURE LINE ALARMING. THE NEXT DAY UNIT CHECKED. RECALIBRATED. STILL SHOWING ERROR. BAXTER SUPPORT CONTACTED. NEW TRANSDUCERS ORDERED. THE NEXT DAY REPLACED TRANSDUCERS. STILL PROBLEM WITH ARTERIAL PRESSURE. BAXTER SUPPORT CONTACTED MULTIPLE TIMES. THE NEXT DAY REPLACED TRANSDUCER PCB. ERROR STILL PRESENT. SERVICE REP IN REPORTEDLY FIXED UNIT. UNIT IN USE ON PT FOUR DAYS LATER. INTERMITTENTLY FUNCTIONING BUT CIRCUIT CLOTTING OFF. AT 0400 RESUMED HEMOFILTRATION, PT CONDITION DETERIORATED EXPIRED 0555.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD MONITOR PUMP HEMOFILTRATION UNIT FIR BAXTER HEALTHCARE CORP BM11A *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death