BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4908494 · Received July 9, 2015

    Report

    Report Number
    1828100-2015-00560
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 16, 2015
    Report Date
    September 18, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR#: 1828100-2015-00459.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. THE PRODUCT SURVEILLANCE INVESTIGATOR WAS ABLE TO DUPLICATE THE EFFECTS ON THE MANUFACTURER'S OPERATING ROOM SIMULATOR SYSTEM 1 WITH THE ASSISTANCE FROM TECHNICAL SUPPORT. THE WAY THE CCM HANDLES THE OCCLUDER SLIDER DISPLAY CAUSES A SOMETIMES PERCEPTIBLE JUMP IN THE DISPLAYED SLIDER FOR THE OCCLUDER. WHEN THE OCCLUDER ¿OPEN¿, ¿CLOSE¿, OR ¿CALIBRATE¿ BUTTON IS PUSHED, THE CCM SOFTWARE DISPLAYS THE SLIDER AT THE FULLY OPENED OR CLOSED POSITION. THEN, AS THE OCCLUDER SUBSYSTEM MECHANICALLY MOVES TO THE USER-COMMANDED POSITION, IT SENDS OUT PLUNGER POSITION UPDATES TO THE SYSTEM AS IT OPENS/CLOSES. THE CCM RECEIVES THESE UPDATES, AND UPDATES THE SLIDER POSITION TO MATCH THIS INFORMATION. THE FULLY-OPENED OR FULLY-CLOSED COMMAND ALREADY INVOKED THEN DIRECTS THE SYSTEM TO DISPLAY THE SLIDER IN ITS FULLY OPEN OR CLOSED POSITION AGAIN. THE END RESULT IS A SOMETIMES PERCEPTIBLE JUMP IN THE DISPLAYED SLIDER POSITION. THE OCCLUDER OPERATION IS NOT AFFECTED BY THIS DISPLAY EFFECT, AND THIS DISPLAY EFFECT IS NOT INDICATIVE OF AN ISSUE WITH THE OCCLUDER SUBSYSTEM. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USER OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE OCCLUDER WAS NOT CALIBRATING PROPERLY. THE SLIDER BAR ON CENTRAL CONTROL MONITOR (CCM) JUMPED AT THE END CALIBRATION. THE CUSTOMER IS STILL USING OCCLUDER AND ALSO TUBE CLAMPS WHEN NEEDED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445585 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 806455

    Patients

    Seq Age Sex Outcome Treatment
    1