BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4137847 · Received September 29, 2014

    Report

    Report Number
    1828100-2014-00822
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Report Date
    September 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2014-00659. PER THE LABORATORY EVALUATION, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED THE CENTRAL CONTROL MONITOR (CCM) REBOOTING. THE PST DISCONNECTED THE SINGLE BOARD COMPUTER (SBC) BOARD AND INSPECTED CONNECTORS. THERE WERE NO ISSUES FOUND. THE PST RECONNECTED THE CUSTOMER SBC BOARD AND POWERED ON AND OBSERVED THE CCM REBOOTING. THE PST POWERED DOWN THE CCM, REPLACED CUSTOMER SBC BOARD WITH LAB-USE ONLY SBC BOARD AND POWERED ON. THE PST OBSERVED THE CCM TO BOOT PROPERLY AND FUNCTION NORMALLY. HE REBOOTED TEN TIMES AND OBSERVED THE CCM TO BOOT PROPERLY EACH TIME, DETERMINING THE CUSTOMER SBC BOARD WAS DEFECTIVE. 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.

    Description of Event or Problem · 1

    THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THERE WAS A DEFECTIVE SINGLE BOARD COMPUTER (SBC) BOARD IN THE CENTRAL CONTROL MONITOR (CCM). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606883 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CCM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1