BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2211110 · Received August 5, 2011

    Report

    Report Number
    1828100-2011-02358
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THAT THE AIR DETECTOR LATCH WAS BROKEN. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, 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 AIR BUBBLE DETECTOR MODULE DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 5773

    Patients

    Seq Age Sex Outcome Treatment
    1