BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CARDIOVASCULAR SYSTEM CORP

    MDR report key: 2312215 · Received October 21, 2011

    Report

    Report Number
    1828100-2011-03234
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 23, 2011
    Report Date
    October 21, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. VISUAL EXAMINATION. COMPONENT/SUBASSEMBLY FAILURE (INDICATOR). NOTE: THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS ATTRIBUTED TO DAMAGE.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THAT THE INDICATOR RING WAS WORN AND DAMAGED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CARDIOVASCULAR SYSTEM CORP ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1