BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 15890020 · Received November 30, 2022

    Report

    Report Number
    1828100-2022-00408
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 9, 2022
    Report Date
    January 24, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    UDI-DI
    00886799001325
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE CCM. THE UNIT PASSED TESTING. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATION.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED ERRORS UPON THE BOOT UP OF THE CENTRAL CONTROL MONITOR (CCM) INCLUDING AN UNUSUAL SPLASH SCREEN AND A QNX SOFTWARE MESSAGE. AN UNUSUAL GREEN SCREEN SAVER WAS ALSO OBSERVED APPEARING AFTER FIVE MINUTES OF IDLE TIME. THE CCM WAS LEFT ON OVERNIGHT TO SEE IF THE OTHER SCREEN SAVER CAME ON, BUT THE UNUSUAL SCREEN SAVER WAS STILL RUNNING, AND THE PERFUSION SCREEN WAS DISPLAYED UPON TOUCHING THE SCREEN. IT WAS DETERMINED THAT THE CCM DID NOT MEET SPECIFICATION. PER THE FIELD SERVICE REPRESENTATIVE (FSR), QNX IS AN OPERATING SYSTEM OF THE CCM AND COMES INSTALLED FROM THE MANUFACTURER. THE CCM HAS AN ENABLED SCREENSAVER THAT SHOULD ONLY BE THE BOUNCING BUBBLES AND THERE IS NO OPTION FOR THE END USER TO CHANGE IT. THE UNUSUAL GREEN SCREEN SAVER IS AN OPTION THAT COULD BE SELECTED BUT IS NOT USED BY THE MANUFACTURER. A CORRUPTED HARD DRIVE WOULD LIKELY CAUSE THE ISSUE. THE SERVICE REPAIR TECHNICIAN (SRT) OBSERVED THE ISSUE TO BE RESOLVED WITH THE REPLACEMENT OF THE HARD DRIVE. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. 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 · 0

    IT WAS REPORTED THAT THE CENTRAL CONTROL MONITOR (CCM) SCREEN WAS NOT BOOTING UP TO THE CORRECT SCREEN. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769517 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