BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3130080 · Received May 21, 2013

    Report

    Report Number
    1828100-2013-00493
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2013-00522. THE FIELD SERVICE REPRESENTATIVE (FSR) SPOKE WITH THE CUSTOMER AND THEY CONFIRMED THAT THE USER NEVER REASSIGNED THE TEMPERATURE MODULES IN THE BEGINNING OF THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE PERFUSIONIST (CCP) SWITCHED OUT THE TEMPERATURE MODULES FROM ONE SYSTEM TO ANOTHER AND THE TEMPERATURES WERE FLUCTUATING. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225346 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 802114

    Patients

    Seq Age Sex Outcome Treatment
    1