BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2152572 · Received June 27, 2011

    Report

    Report Number
    1828100-2011-01803
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 27, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    JOR
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE REP REPORTED THAT THE MANUAL SWITCH LABEL WAS WORN OFF THE COVER. 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 PERFUSION SYSTEM 8000 ROLLER PUMP JOR TERUMO CARDIOVASCULAR SYSTEM CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1