BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2100194 · Received May 16, 2011

    Report

    Report Number
    1828100-2011-01343
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 16, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER NOTICED THAT RED X'S WOULD APPEAR INTERMITTENTLY ON THE CENTRAL CONTROL MONITOR OF THE SYSTEM-1 OVER THREE OF THE ROLLER PUMP ICONS. THESE THREE PUMPS WERE ASSIGNED AS SUCKERS AND A VENT. THE PUMPS WOULD OCCASIONALLY RESET AND GO TO THE STOP MODE. THE USER ELECTED TO CHANGE OUT THE ENTIRE HEART-LUNG MACHINE SYSTEM. THE CASE WAS DELAYED 20 MINUTES. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE 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 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1