BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO HEART LUNG MACHINE

    MDR report key: 3777664 · Received April 28, 2014

    Report

    Report Number
    3777664
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC SURGERY, WHILE THE PATIENT WAS ON CARDIAC BYPASS, THE MACHINE UNEXPECTEDLY SHUT DOWN. AN ATTEMPT TO RE-START THE MACHINE WAS UNSUCCESSFUL AND HAND CRANKING WAS REQUIRED WHILE ANOTHER BYPASS MACHINE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254065 TERUMO HEART LUNG MACHINE TERUMO HEART LUNG MACHINE DTQ TERUMO MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening