BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3862875 · Received February 20, 2014

    Report

    Report Number
    1828100-2014-00126
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 29, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBSIDIARY SERVICE ENGINEER REPLACED THE TOUCH SCREEN CONTROLLER BOARD, HOWEVER, IT DID NOT CORRECT THE REPORTED ISSUE. SUBSIDIARY EVALUATION IS STILL ONGOING. PER MANUFACTURER TECHNICAL SUPPORT, HE ADVISED THE SUBSIDIARY TO TRY RESEATING THE CABLES AND TO SEE IF THERE IS ANY OXIDATION ON THE CONNECTIONS FROM THE CABLES TO THE BOARDS. IF IT IS THE TOUCH SCREEN, IT WILL NEED TO BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CURSOR ARROW ON THE CENTRAL CONTROL MONITOR (CCM) COULD NOT BE MOVED ON THE SCREEN AS USER WANTED. THEY HAVE CALIBRATED SCREEN MANY TIMES, BUT THE PROBLEM IS NOT FIXED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106759 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (XXX) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1