BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1022198 · Received March 26, 2008

    Report

    Report Number
    1828100-2008-00163
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS, THE USER OBSERVED A MESSAGE THAT THE GAS SYSTEM REQUIRED SERVICE. MANUAL CONTROL OF THE GAS DELIVERY REMAINED AVAILABLE. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT AS A RESULT OF THIS EVENT.

    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 SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1