BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2153465 · Received June 21, 2011

    Report

    Report Number
    1828100-2011-01741
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 21, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING SYSTEM 1 SET UP, AND PRIOR TO IT BEING COMPLETED BOOTED UP, THE USER REPORTED THAT THEY WERE NOT ABLE TO GET GAS FLOW USING THE ELECTRONIC PATIENT GAS SYSTEM MANUAL CONTROLS. AFTER GAS FLOW WAS ESTABLISHED USING THE CENTRAL CONTROL MONITOR SLIDERS, THE USER DISCOVERED THAT HE WAS TURNING THE GAS FLOW KNOBS IN THE WRONG DIRECTION. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT. THE UNIT IS NOT GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE GAS MODULE DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1