BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 2518410 · Received April 3, 2012

    Report

    Report Number
    1124841-2012-00017
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    January 24, 2012
    Report Date
    March 1, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO RECEIVED THE ACTUAL SAMPLE AND THE INVESTIGATION WAS COMPLETED ON (B)(4) 2012. PERFORMANCE TESTING CONFIRMED THE COMPLAINT, THE DEVICE LEAKED. IT IS MOST LIKELY THAT THE DEVICE WAS ON THE LOWER END OF ADHESIVE INJECTION VOLUME FOR THE PRIMARY ADHESIVE RING, AND THAT THE TECHNIQUE USED IN THE APPLICATION PROCESS DID NOT ALLOW FOR OPTIMAL DISPERSION AROUND THE OPENING. THE DEVICE WAS SUFFICIENTLY CURED TO PASS THROUGH THE 100% LEAK TEST, BUT NOT ENOUGH TO ENDURE SHIPPING, HANDLING, AND PRESSURE CHANGES. THE COMPLETED INVESTIGATION AND ADD¿L INFO DEEMED THIS MDR REPORTABLE ON (B)(4) 2012. (B)(4). METHOD - ACTUAL DEVICE ¿ COMPONENT/SUBASSEMBLY FAILURE. CONCLUSIONS ¿ DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. ALL INFO HAS BEEN PLACED ON FILED WITH QUALITY MANAGEMENT FOR APPROPRIATE TENDING, TRACKING, AND FOLLOW-UP.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUNT SENSOR SYS500 BLOOD -GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CD1510H NM26A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK