BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 3252502 · Received July 25, 2013

    Report

    Report Number
    1828100-2013-00686
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET RECEIVED. THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT DUPLICATE PROBLEM. THE FSR INSTALLED A NEW LEVEL SENSOR ASSEMBLY THOROUGHLY WITHOUT ISSUE. THE SUSPECT COMPONENTS WERE RETURNED TO THE MFR FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE LEVEL SENSOR ON THE SAFETY MONITOR DID NOT ALARM. THE CUSTOMER CHANGED THE SENSOR AND THE MONITOR WAS STILL NOT RESPONDING. AS A RESULT, AN ALTERNATIVE DEVICE WAS EMPLOYED AND THE SUSPECT DEVICE WAS PULLED FROM SERVICE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347170 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16404

    Patients

    Seq Age Sex Outcome Treatment
    1