BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 10111831 · Received June 2, 2020

    Report

    Report Number
    1828100-2020-00205
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 8, 2020
    Report Date
    June 8, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799001325
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) POWERED ON THE CENTRAL CONTROL MONITOR (CCM) AND OBSERVED THE UNIT TO BOOT TO THE QNX PHOTON GUI INSTEAD OF THE SPLASH SCREEN. HE REPLACED THE HARD DRIVE WITH A LAB USE ONLY HARD DRIVE AND THE UNIT BOOTED UP NORMALLY, DETERMINING THAT THE CCM HARD DRIVE WAS DEFECTIVE. THE PRODUCT WAS SENT TO SERVICE TO BE BROUGHT TO THE MANUFACTURER¿S SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. 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

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRAL CONTROL MONITOR (CCM) DID NOT BOOT PROPERLY TO THE SPLASH SCREEN, RATHER IT BOOTED TO QNX PHOTON GRAPHICAL USER INTERFACE (GUI). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576491 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