BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 4110627 · Received September 16, 2014

    Report

    Report Number
    1124841-2014-00143
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 28, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    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 AT 200 MMHG POSITIVE PRESSURE. THE COMPLAINT UNIT WAS FOUND TO LEAK FROM BOTH THE LARGE AND SMALL BORE ENDS. A REVIEW OF THE DEVICE HISTORY REVEALED NO ANOMALIES WHICH WOULD CONTRIBUTE TO A LEAK AT THE WELD. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS THE RECENT CHANGE IN WELDING SPECS HAS MAGNIFIED THE EFFECT OF SLIGHT VARIATIONS IN FIT BETWEEN THE INSERT AND BODY TO THE POINT THAT ALTHOUGH IT PASSED THE 100% LEAK TEST IN-PROCESS, IT WAS UNABLE TO MAINTAIN MECHANICAL INTEGRITY THROUGH THE SHIPPING AND HANDLING PROCESS. (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 SYSTEMS CORP THAT DURING CARDIOPULMONARY BYPASS THE SHUNT SENSOR LEAKED BLOOD AT THE LARGE BLUE LUER CAP. <1CC BLOOD LOSS. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572018 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H RD24A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK