BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1063540 · Received June 20, 2008

    Report

    Report Number
    1828100-2008-00313
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 20, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K902198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE CENTRIFUGAL SYSTEM, IT WAS NOTED THAT THE CENTRIFUGAL BATTERY UNIT WAS SHIPPED WITH THE POWER SWITCH IN THE "ON" POSITION. THE BATTERIES WERE DEPLETED. THE FIELD SERVICE REPRESENTATIVE STARTED CHARGING SYSTEM AND COMPLETED A FULL INSPECTION. THERE WAS NO ADVERSE CONSEQUENCE TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL PUMP BATTERY MODULE KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 9490

    Patients

    Seq Age Sex Outcome Treatment
    1