BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1170743 · Received September 15, 2008

    Report

    Report Number
    1828100-2008-00442
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 15, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K902198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE CENTRIFUGAL SYSTEM, IT WAS NOTED THAT THE CENTRIFUGAL CONSOLE WOULD NOT LOCK PROPERLY ONTO THE BATTERY WEDGE. THE CUSTOMER WAS INSTRUCTED BY TECHNICAL SUPPORT TO REMOVE THE LOCK KNOB FROM THE CENTRIFUGAL CONSOLE AND PLACE IT INTO THE SLIDE MECHANISM ON THE WEDGE AND ATTEMPT TO CLOSE THE LOCKING MECHANISM. THE CUSTOMER INDICATED THAT SLIDE MECHANISM WAS TOO THICK. AN ALTERNATE DEVICE WAS EMPLOYED. THERE WAS NO ADVERSE CONSEQUENCE TO A PATIENT 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 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 9490

    Patients

    Seq Age Sex Outcome Treatment
    1