BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6203836 · Received December 26, 2016

    Report

    Report Number
    1828100-2016-00816
    Event Type
    Malfunction
    Date Received
    December 26, 2016
    Date of Event
    December 2, 2016
    Report Date
    March 23, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K153376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    AS PER FIELD SERVICE REPRESENTATIVE (FSR), THE FACILITY'S BIOMED IS TERUMO TRAINED AND DOES THE IN-HOUSE REPAIRS FOR THIS HOSPITAL. THE BIOMED HAS ALREADY INSPECTED THE UNIT. 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). PER LOG ANALYSIS, THERE ARE NO INDICATIONS OF A PROBLEM IN THE LOG, THE PUMP WORKED AS DESIGNED AND CONFIGURED. THE FIELD SERVICE REPRESENTATIVE (FSR), COULD NOT VERIFY THE REPORTED COMPLAINT. THE FSR TESTED BOTH PUMPS WHICH RAN WITHOUT ANY UNEXPECTED STOPS. THE CARDIOPLEGIA PUMP IS CONFIGURED TO STOP WHEN ARTERIAL PUMP STOPS ON THE SYSTEM. FSR CHECKED OPERATION OF BOTH ROLLER PUMPS, NO PROBLEMS FOUND, ROLLER PUMP FANS OPERATING AND CONNECTIONS ARE OKAY. THE ROLLER PUMP WAS FOUND TO BE OPERATING TO TERUMO SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. 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 USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CARDIOPLEGIA PUMP STOPPED ABRUPTLY WITHOUT ANY ALARM. THE CUSTOMER HAD RESET THE SYSTEM AND CONTINUED TO USE IT THROUGHOUT THE CASE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THIS PUMP (CARDIOPLEGIA) WAS LINKED TO THE ARTERIAL PUMP AND THIS PUMP DID STOP ON TWO OCCASIONS WHEN THE ARTERIAL PUMP STOPPED. THERE IS NO INDICATION OF MALFUNCTION, AS THE PUMP STOPPED AS CONFIGURED. THE USER MAY HAVE BEEN CONFUSED BY THIS BEHAVIOR, BUT THE CARDIOPLEGIA PUMP WAS NOT ACTUALLY MOVING (DELIVERY CARDIOPLEGIA) WHEN THE LINKED ARTERIAL PUMP STOPPED. THE CASE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854292 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816570

    Patients

    Seq Age Sex Outcome Treatment
    1