BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3042489 · Received April 4, 2013

    Report

    Report Number
    1828100-2013-00329
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) VERIFIED THE CUSTOMER'S COMPLAINT OF "BELT SLIP" ALARM VIA A VIDEO, BUT COULD NOT DUPLICATE THE REPORTED ISSUE. THE FSR REPLACED THE DRIVE BELT AND SET CORRECT TENSION. WITH THE BELT REPLACED AND TENSION SET, THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION 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

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THAT A "BELT SLIP" ERROR OCCURRED ON THE ROLLER PUMP TWO HOURS INTO THE PROCEDURE WHEN THE REVOLUTIONS PER MINUTE (RPMS) WERE BEING REDUCED. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138019 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 16402

    Patients

    Seq Age Sex Outcome Treatment
    1