BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2181032 · Received July 1, 2011

    Report

    Report Number
    1828100-2011-01813
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE USER OBSERVED THAT THERE WERE NO LITERS PER MINUTE READING ON THE CENTRAL CONTROL MONITOR AND THE CENTRIFUGAL CONTROL MODULE. SINCE THE EVENT OCCURRED DURING FIELD SERVICE INSTALLATION, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 FLOW MODULE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 802018

    Patients

    Seq Age Sex Outcome Treatment
    1