BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 10214531 · Received June 30, 2020

    Report

    Report Number
    1828100-2020-00237
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 5, 2020
    Report Date
    December 15, 2021
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799001325
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER DATA LOG ANALYSIS, ON (B)(6) 2020 THE PERFUSION SCREEN WAS OPENED. AT 09:00:53 AM THE CENTRAL CONTROL MONITOR (CCM) STOPPED LOGGING AND WAS NOT POWERED UP AGAIN UNTIL 12:21:51 PM. WHEN THE CCM STOPPED LOGGING, THE OTHER PUMPS AND MODULES CONTINUED TO FUNCTION AS REPORTED. WHEN THE CCM FROZE THE LOCAL AREA NETWORK/INTERFACE BOARD (LAN I/F) ALSO CONTINUED TO RUN. THIS INDICATES A HARDWARE ISSUE WITH THE CCM (INTERMITTENT). THE CCM SHOULD BE THOROUGHLY TESTED. IT COULD BE AN ISSUE WITH THE FLEX CABLE THAT CONNECTS THE SINGLE BOARD COMPUTER (SBC) TO THE LAN I/F.

    Additional Manufacturer Narrative · 0

    DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED THE CENTRAL CONTROL MONITOR (CCM) TO RUN FOR ABOUT 50 HOURS WITH NO OBSERVATION OF THE SCREEN FREEZING.

    Additional Manufacturer Narrative · 0

    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

    THE FIELD SERVICE REPRESENTATIVE (FSR) REMOVED AND REPLACED THE SUSPECT CCM AND INSTALLED NEW BATTERIES. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE SUSPECT UNIT WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    PRIOR TO USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) SCREEN FROZE UP. AS A MITIGATION, LOCAL CONTROLS WERE USED TO CONTINUE THE SURGERY. 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
    677446 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816300 00886799001325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown