BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 7712490 · Received July 23, 2018

    Report

    Report Number
    1828100-2018-00379
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 31, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K163531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED

    Additional Manufacturer Narrative · 1

    DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) VERIFIED THE REPORTED COMPLAINT. HE OBSERVED THE CENTRAL CONTROL MONITOR (CCM) TO REBOOT DURING POWER UP. REPLACEMENT OF THE SINGLE BOARD CIRCUIT (SBC) BOARD WITH A LAB USE ONLY (LUO) SBC BOARD RESTORED THE UNIT'S FUNCTIONALITY. THE SERVICE REPAIR TECHNICIAN (SRT) OBSERVED THE UNIT TO BOOT UP WITH A SYSTEM DISK FAILURE WHICH CAN HAPPEN WHEN THE SBC BOARD IS REMOVED AND REINSTALLED. UPON OPENING THE UNIT HE FOUND THE SBC COIN BATTERY TO BE IMPROPERLY INSTALLED IN THE SBC BOARD CAUSING DAMAGED TO THE POSITIVE TERMINAL OF THE BATTERY HOLDER. CORRECTION OF THE INSTALLATION OF THE COIN BATTERY RESTORED PROPER FUNCTIONALITY. HE REPLACED THE SBC BOARD AND SBC COIN BATTERY. THE PRINTED CIRCUIT INTERFACE (PCI) BUS CABLE WAS REPLACED AS PRECAUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) KEPT REBOOTING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554139 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816300

    Patients

    Seq Age Sex Outcome Treatment
    1