BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6128181 · Received November 27, 2016

    Report

    Report Number
    1828100-2016-00762
    Event Type
    Malfunction
    Date Received
    November 27, 2016
    Date of Event
    November 2, 2016
    Report Date
    February 8, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K151349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING LAB ANALYSIS, THE REPORTED COMPLAINT WAS DUPLICATED DURING EVALUATION. THE DEVICE UNDER TEST (DUT) WILL NOT RUN ON BATTERY POWER WITH AC POWER IS REMOVED FROM THE SYSTEM. THE CAUSE IS THE OPEN RESISTOR (R12) ON POWER MANAGER PRINTED CIRCUIT BOARD. IT APPEARS TO BE BURNT AND HAS CRACKED ACROSS THE RESISTIVE ELEMENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE BATTERIES BUT HE WAS HAVING THE SAME PROBLEM. THROUGH TROUBLE SHOOTING, THE FSR DETERMINED THE POWER MANAGER BOARD HAD FAILED TO SUPPLY BATTERY BACKUP TO THE HEART LUNG MACHINE. THE FSR REPLACED THE POWER MANAGER BOARD, COMPLETED THE PREVENTATIVE MAINTENANCE AND THE SYSTEM PERFORMED TO MANUFACTURERS SPECIFICATIONS. THE POWER MANAGER BOARD WILL BE RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT WAS CONFIRMED. 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

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT AFTER THE COMPLETION OF THE NOTICE OF FIELD CORRECTION SERVICE, THE BATTERIES HAD LOST THEIR ABILITY TO CARRY THE NECESSARY LOAD TO POWER THE SYSTEM ONE. THE BATTERY BACK-UP WAS TESTED AND FOUND OUT THAT SYSTEM ONE COMPLETELY SHUTS DOWN WHEN PLUG DISCONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778998 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1