BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3810989 · Received March 23, 2014

    Report

    Report Number
    1828100-2014-00233
    Event Type
    Malfunction
    Date Received
    March 23, 2014
    Date of Event
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THAT THE YELLOW LEVEL SENSOR INDICATED "DISCONNECTED". THE FSR REPLACED THE LEVEL SENSOR AND COMPLETED PREVENTATIVE MAINTENANCE (PM). THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT LEVEL SENSOR WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE LEVEL SENSOR "DISCONNECTED" YELLOW LIGHT WAS ON, BUT UNIT WAS FUNCTIONING. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171296 TERUMO PERFUSION SYSTEM 8000 8K DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195215

    Patients

    Seq Age Sex Outcome Treatment
    1