BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 7626277 · Received June 21, 2018

    Report

    Report Number
    1828100-2018-00322
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    May 30, 2018
    Report Date
    October 17, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTQ
    PMA / PMN Number
    K172220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT WAS CONFIRMED. ADDITIONAL LABORATORY ANALYSIS WAS DONE BY THE PRODUCT SURVEILLANCE TECHNICIAN (PST) AND HE OBSERVED THAT THE HARD DRIVE WAS DISCONNECTED FROM THE ENHANCED INTEGRATED DRIVE ELECTRONICS (EIDE) PRINTED CIRCUIT BOARD (PCB). HE RECONNECTED THE HARD DRIVE TO THE EIDE PCB AND TESTED IT FOR ONE HOUR WITH NO ISSUES. 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

    DURING LABORATORY ANALYSIS, THE PST OBSERVED THE ERROR MESSAGE UPON BOOTING UP THE CCM. THE CCM WAS REBOOTED FIVE TIMES WITH THE SAME RESULT. THE HARD DRIVE OF THE CCM WAS FOUND TO BE DEFECTIVE. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO 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.

    Description of Event or Problem · 1

    THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A 'DISK BOOT FAILURE, INSERT SYSTEM DISK AND PRESS ENTER' ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469339 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 816300

    Patients

    Seq Age Sex Outcome Treatment
    1