BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYTEM 1

    MDR report key: 2960991 · Received January 30, 2013

    Report

    Report Number
    1828100-2013-00083
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CARDIOPULMONARY BYPASS OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE CENTRAL CONTROL MONITOR (CCM) SCREEN WAS SCRAMBLE. THE PERFUSIONIST (CCP) COULD NOT READ ANYTHING ON THE SCREEN. THE DEVICE WAS NOT CHANGED OUT, AS THE CCP USED THE CCM FOR THE CASE. THE PROCEDURE WAS DELAYED APPROXIMATELY TEN MINUTES, AS THE ENTIRE SYSTEM ONE UNITE WAS REBOOTED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO BLOOD LOSS OR N ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40126 TERUMO ADVANCED PERFUSION SYTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1