BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 3756381 · Received February 14, 2014

    Report

    Report Number
    1124841-2014-00013
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 30, 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

    UPON EVAL OF THE DEVICE THE COMPLAINT WAS CONFIRMED. THE UNIT WAS VISUALLY INSPECTED AND PRESSURIZED, AND A LEAK WAS OBSERVED AT THE THERMOWELL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THIS UNIT WAS SUFFICIENTLY CURED AND SEALED TO PASS THROUGH A 100 PERCENT LEAK TEST. THE ROOT CAUSE, A LEAK FROM THE THERMOWELL POSITION RESULTING FROM STRESS, WAS IDENTIFIED TO BE SHIPPING AND HANDLING PAIRED WITH THE COUPLING OF THE SENSOR TO THE BPM HEAD. (B)(4). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEM CORPORATION THAT AFTER CARDIOPULMONARY BYPASS, IT WAS NOTED THAT THE SHUNT SENSOR LEAKED BLOOD. THE BLOOD LEAK WAS OBSERVED AFTER THE SHUNT SENSOR WAS REMOVED FROM THE BPM UPON TERMINATION OF THE PROCEDURE. <1CC BLOOD LOSS. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97199 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H QL03A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK