BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 16986799 · Received May 23, 2023

    Report

    Report Number
    1828100-2023-00148
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    April 28, 2023
    Report Date
    July 28, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799000588
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS NOT VERIFIABLE SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION OR TESTING. MULTIPLE DILIGENCE ATTEMPTS FOR PART RETURN WERE UNSUCCESSFUL. 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 · 0

    PER THE MANUFACTURER'S SUBSIDIARY'S FIELD SERVICE ASSOCIATE, A NEW O2 SENSOR WAS INSTALLED BUT THE PROBLEM REMAINED. A MECHANICAL BLENDER WAS LEFT INSTALLED.

    Description of Event or Problem · 0

    CALIBRATION FAILED. ERROR MESSAGE "O2 ANALYZER CALIBRATION NOT POSSIBLE 232897".

    Description of Event or Problem · 0

    UPON RECEIPT OF THE DEVICE, THE FIELD SERVICE ENGINEER REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED AN 'OXYGEN (O2) ANALYZER CALIBRATION NOT POSSIBLE' MESSAGE AND THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) FAILED CALIBRATION MULTIPLE TIMES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244565 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 801188 00886799000588

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MECHANICAL FLOW METER