BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 19490159 · Received June 7, 2024

    Report

    Report Number
    1828100-2024-00154
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 15, 2024
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799000588
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THE PREVIOUSLY SUBMITTED MEDWATCHES RELATED TO THIS COMPLAINT. THERE WAS NO MALFUNCTION IN THE INTENDED PERFORMANCE ASSOCIATED WITH THE SERVICE MESSAGE AS THE DEVICE PERFORMED TO SPECIFICATIONS. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) CONNECTED THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) TO LAB USE ONLY (LUO) TESTING EQUIPMENT. UPON POWER UP OF THE EPGS PERFUSION SCREEN, THE PST OBSERVED A 'SERVICE GAS SYSTEM' MESSAGE AND CALIBRATION WAS UNAVAILABLE. IN THE SERVICE SCREEN, IT WAS NOTED THAT THE OXYGEN (O2) PERCENT HOURS READ 2211802. AFTER 2000000% HOURS, THE SYSTEM ALERTS THE USER TO 'SERVICE GAS SYSTEM'. THE UNIT OPERATED AS INTENDED. 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

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 0

    IT WAS THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'GAS BLENDER FAILURE' MESSAGE. 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
    2125190 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 NA Unknown