BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2160428 · Received June 20, 2011

    Report

    Report Number
    1828100-2011-01759
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 20, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE BOX THAT USUALLY APPEARS ON THE CENTRAL CONTROL MONITOR THAT COUNTS UP TO 10 BEFORE INDICATING IT IS OKAY TO TURN THE POWER SWITCH TO THE OFF POSITION WAS EMPTY AND NO NUMBERS WERE DISPLAYED. THE SERVICE ASSOCIATE VISITED THE SITE AND COULD NOT DUPLICATE THE EVENT AND REVIEW OF THE LOGS DID PROVIDE ANY INFORMATION RELATED TO THIS COMPLAINT. THE UNIT IS NOT BEING RETURNED AND THE USER CONTINUES TO USE THE UNIT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1