BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2884788 · Received December 3, 2012

    Report

    Report Number
    1828100-2012-01519
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT CONCLUDED. THE DEVICE WAS CHANGED FROM THE ARTERIAL LOCATION TO A SUCTION FUNCTION AFTER THE CASE WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE ROLLER PUMP STOPPED FOR APPROXIMATELY TEN SECONDS AND THE ALARM DID NOT ACTIVATE. THE PERFUSIONIST WAS ABLE TO IMMEDIATELY RE-START THE PUMP AND THERE WERE NO OTHER ISSUES FOR THE REMAINDER OF THE PROCEDURE. 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. THE PT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1