BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6203710 · Received December 25, 2016

    Report

    Report Number
    1828100-2016-00812
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    November 30, 2016
    Report Date
    March 23, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K151349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). AS PER LEAD SERVICE REPAIR TECHNICIAN, UNIT WAS POWER CYCLED, AND THE ISSUE WAS RESOLVED. THE UNIT WAS DISASSEMBLED AS A PRE-CAUTION. FLAT PANEL INTERFACE NODE CONTROLLER (FPINC) BOARD WAS REMOVED AND INSPECTED. NO ISSUES WERE OBSERVED. REASSEMBLED ENSURING ROBUST CONNECTION OF ALL CONNECTORS, AND MONITOR PASSED POWER ON CHECKS AND RELEASE TESTING. 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 SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SCREEN DISPLAYED VERTICAL COLORED LINES UPON FIRST POWER ON OF THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853700 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1