BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMEDICUS/MEDTRONIC PHYSIO-CONTROL

    MDR report key: 297542 · Received September 22, 2000

    Report

    Report Number
    MW1019992
    Event Type
    Death
    Date Received
    September 22, 2000
    Date of Event
    August 25, 2000
    Report Date
    September 5, 2000
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PERFUSIONIST ATTEMPTED TO DELIVER 4 LITERS BUT WAS CONCERNED ABOUT FORCE BEING LOW. HE WAS ONLY ABLE TO DELIVER 1.5 LITERS. THEY SUSPECTED A PULMONARY DEEP VEIN EMBOLUS. THE BATTERY POWER WAS LOW, BUT UNIT WAS CONNECTED TO HOSP A-C LINE. PERFUSIONIST WANTED CONFIRMATION THAT PUMP WAS OPERATING UP TO SPECS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/27/00: MFR HAS REVIEWED THE REPORTED INCIDENT AND DETERMINED THAT A MEDWATCH WOULD NOT BE FILED AT THIS TIME. THE DEVICE INVOLVED IN THE INCIDENT HAD BEEN EVALUATED BY BOTH THE HOSP'S BIOMEDICAL DEPT AND MFR'S OWN SVC REP. THE INCIDENT COULD NOT BE DUPLICATED. HOSP PERSONNEL INDICATED TO MEDTRONIC PERFUSION SYSTEMS THAT THE PROBLEM WAS MORE PHYSIOLOGICAL THAN EQUIPMENT RELATED. THE UNIT WAS NOT CHANGED OUT DURING THE PROCEDURE AND IS CURRENTLY IN USE AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMEDICUS/MEDTRONIC PHYSIO-CONTROL PUMP, BLOOD DTQ MEDTRONIC PHYSIO-CONTROL 540, 540T, TX40 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death