BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 1775825 · Received July 22, 2010

    Report

    Report Number
    1828100-2010-01000
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 22, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 SIGNAL STRENGTH OF THE CONTROL MODULE WAS OUT OF SPECIFICATION. THE SIGNAL STRENGTH REGISTERED AT 31%, WHILE THE SPECIFICATION IS 50%. THE FIELD SERVICE REP REPORTED THAT THE FLOW READINGS WERE STEADY AND CORRECT. THERE WAS CORROSION FOUND ON THE D CONNECTOR, WHERE THE FLOW SENSOR ATTACHES TO THE CONTROL MODULE. SINCE THIS EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL CONTROL MODULE DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 6379

    Patients

    Seq Age Sex Outcome Treatment
    1