BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1935830 · Received December 3, 2010

    Report

    Report Number
    1828100-2010-02364
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE USER REPORTED THE FLOW SENSOR WOULD NOT CONSISTENTLY LATCH AS EXPECTED WITH THE TUBING INSERTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM FLOW SENSOR DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 6382

    Patients

    Seq Age Sex Outcome Treatment
    1