BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6026365 · Received October 13, 2016

    Report

    Report Number
    1828100-2016-00674
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 19, 2016
    Report Date
    December 30, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K151349
    Removal / Correction Number
    1828100-06/05/2007-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE SYSTEM WAS LAST SERVICED INCLUDING SOFTWARE WAS UPGRADE PER NOTICE OF FIELD CORRECTION (NFC) ON 16-SEP-2016.

    Additional Manufacturer Narrative · 1

    DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED ¿SYSTEM COMPUTER NEEDS SERVICE¿ MESSAGE DURING BOOT PROCESS, DUPLICATING THE COMPLAINT CONDITION. REPLACEMENT OF CUSTOMER DISK-ON-CHIP WITH LAB USE ONLY (LUO) DISK-ON-CHIP RESTORED CENTRAL CONTROL MONITOR (CCM)'S FUNCTIONALITY. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURERS 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

    THE REPORTED COMPLAINT WAS CONFIRMED. 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

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE "SYSTEM COMPUTER NEEDS SERVICE" ERROR DISPLAYED AT POWER UP ON THE CENTRAL CONTROL MONITOR (CCM). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677958 TERUMO ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1