BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3802442 · Received February 21, 2014

    Report

    Report Number
    1828100-2014-00143
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 30, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00067 AND MDR #1828100-2014-00068. THE FIELD SERVICE REPRESENTATIVE (FSR) DOWNLOADED THE SOFTWARE DATA LOGS AND VERIFIED THE OCCLUDER OPERATED TO MANUFACTURER SPECIFICATIONS BEFORE BEING RETURNED TO CLINICAL USE. SOFTWARE DATA LOGS WERE RETURNED TO THE MANUFACTURER ON 01/31/2014 FOR FURTHER EVAL. AFTER EXAMINING THE DATA LOGS, THE MANUFACTURER'S TECHNICAL SUPPORT BELIEVES THE LOGS SHOW THAT THE USER SOMETIMES CALIBRATED THE OCCLUDER WITHOUT TUBING INSTALLED. IT IS THEN BELIEVED THAT THIS INCORRECT USER CALIBRATION METHOD RESULTED IN THE CCP EXPERIENCING THAT THE ACTUAL OCCLUSION ON THE TUBING WAS MUCH GREATER THEN THE OCCLUSION PERCENTAGE INDICATED ON THE CCM SCREEN. THE INCORRECT CALIBRATION ALSO RESULTED IN THE CCP EXPERIENCING: NO FLOW; THE CCM OCCLUSION DISPLAY SHOWING THE "CAL" ICON, WHILE THE CCP EXPECTED FLUID TO STILL BE FLOWING THROUGH THE OCCLUDER HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER WAS HAVING DIFFICULTY WITH THE OCCLUDER (IN CAL MODE) ON THE PERFUSION SYSTEM. THEY DISCONNECTED THE OCCLUDER SYSTEM AND ARE USING MANUAL CLAMPS. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110324 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164560

    Patients

    Seq Age Sex Outcome Treatment
    1