BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED PERFUSION SYSTEM 1

    MDR report key: 6121317 · Received November 22, 2016

    Report

    Report Number
    1828100-2016-00755
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 30, 2016
    Report Date
    November 22, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM 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

    (B)(4). COMPONENT CODE : 886-MONITOR, 416-DISPLAY. THE REPORTED COMPLAINT WAS CONFIRMED PER LABORATORY EVALUATION. THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED NO DISPLAY ON THE CCM WHEN POWER WAS APPLIED. THE CLEANING OF THE PERIPHERAL COMPONENT INTERCONNECT (PCI) CABLE RESOLVED THE PROBLEM. 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 MANUFACTURER TRAINED BIOMED REPORTED THAT DURING OTHER NON-CLINICAL ACTIVITY THE CENTRAL CONTROL MONITOR (CCM) HAD A BLACK SCREEN ON THE DISPLAY. THE ROLLER PUMPS INFORMATION WAS NOT VISIBLE ON THE CCM. IT APPEARED THAT THE SYSTEM'S COMPUTER WAS NOT COMMUNICATING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771378 ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 816300

    Patients

    Seq Age Sex Outcome Treatment
    1