BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3012971 · Received March 1, 2013

    Report

    Report Number
    1828100-2013-00208
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    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

    THE SERVICE REPAIR TECH (SRT) REMOVED THE PUMP MODULE FROM THE HOUSING AND OBSERVED A WOBBLE IN THE LARGE PULLEY. THE SRT REMOVED THE GUT AND OBSERVED BEARING FLUID CONTAMINATION ON LARGE PULLEY. THE SRT REPLACED THE PULLEY, MAIN BEARING, OIL RING AND COMPLETED PREVENTATIVE MAINTENANCE. WITH THESE COMPONENTS REPLACED, THE UNIT OPERATED TO MFR SPECS AND WAS RETURNED TO CLINICAL USE. IF ADD'L INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SERVICE REPAIR TECH (SRT) REPORTED THAT DURING FUNCTIONAL TESTING OF THE DEVICE AT THE SERVICE CENTER, THERE WAS A SLIGHT RUBBING SOUND DURING GUT ROTATION OF THE ROLLER PUMP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90352 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16402

    Patients

    Seq Age Sex Outcome Treatment
    1