BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 4092742 · Received August 20, 2014

    Report

    Report Number
    1124841-2014-00126
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CUSTOMER FOUND A LEAK FROM THE VENT LUER ADAPTOR AND FURTHER TIGHTENED THE JOINT. THE JOINT TIGHTENED, YET THE LEAK CONTINUED. THE CUSTOMER CHANGED OUT THE SHUNT SENSOR, AND THE LEAK STOPPED. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500548 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H RD24A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK