BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 1733100 · Received June 15, 2010

    Report

    Report Number
    1828100-2010-00712
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 15, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE, THE USER REPORTED THE TRIAL KIT WAS LEFT OUT IN THE RAIN AFTER A MECHANISMS SHOW THAT CAUSED 9 ADAPTERS TO RUST. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WERE NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 PERFUSION LIBRARY SOFTWARE JOR TERUMO CARDIOVASCULAR SYSTEMS CORP. 814851

    Patients

    Seq Age Sex Outcome Treatment
    1