BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2172487 · Received June 24, 2011

    Report

    Report Number
    1828100-2011-01779
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE ROLLER PUMP SPUN RAPIDLY UPON STARTUP AND THEN SHUTS OFF. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1