BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 4138585 · Received October 1, 2014

    Report

    Report Number
    1124841-2014-00156
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 16, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    UDI-DI
    00699753160767
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION, AND A LOT NUMBER WAS NOT PROVIDED. RETENTION SAMPLES (LOTS RG16G, RG02G, RF26A) WERE TESTED BASED ON SHIPPING RECORDS TO THE USER FACILITY. THE UNIT WAS VISUALLY INSPECTED AND LEAK TESTED. MICROSCOPIC INSPECTION DID NOT NOTE ANY ANOMALIES, AND LEAK TESTING DID NOT DETECT ANY LEAKS. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. THE EVENT SEEN BY THE CUSTOMER WAS UNABLE TO BE REPRODUCED. THIS UNIT WAS SUFFICIENTLY CURED AND SEALED TO PASS THROUGH A 100% LEAK TEST IN-PROCESS. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE DEVICE WAS NOT RETURNED. (B)(4). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND F/U.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING CARDIOPULMONARY BYPASS THE SHUNT SENSOR LEAKED. <1CC BLOOD LOSS. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614130 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H UNK 00699753160767

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK