BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 3190478 · Received June 21, 2013

    Report

    Report Number
    1124841-2013-00115
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 6, 2013
    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 EVALUATION OF THE DEVICE, THE COMPLAINT WAS CONFIRMED. THE UNIT WAS PERFORMANCE TESTED, AND THE BEHAVIOR OF THE UNIT WAS INDICATIVE OF A LEAK. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO PRODUCTION RELATED ANOMALIES. THE MOST PROBABLE CAUSE OF THE LEAK IS THAT THIS PARTICULAR UNIT WAS ON THE LOWER SIDE OR THE ADHESIVE INJECTION VOLUME FOR THE PRIMARY ADHESIVE RING, AND THE TECHNIQUE BEING USED DID NOT ALLOW FOR THE ADHESIVE TO OPTIMALLY DISPERSE AROUND THE OPENING. THIS UNIT WAS SUFFICIENTLY CURED AND SEALED TO PASS THROUGH OUR 100% LEAK TEST, BUT NOT ENOUGH TO SURVIVE SHIPPING, HANDLING, AND TEMPERATURE/PRESSURE CHANGES. (B)(4). ALL AVAILABLE INFORMATION 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 THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE SHUNT SENSOR LEAKED. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283816 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H PN12D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK