BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 4113633 · Received September 17, 2014

    Report

    Report Number
    1124841-2014-00147
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE DEVICE, THE COMPLAINT WAS NOT CONFIRMED. MICROSCOPIC INSPECTION DID NOT NOTE ANY ANOMALIES IN REGARDS TO THE INTEGRITY OF THE UNIT. LEAK TESTING DID NOT DETECT ANY LEAKS. A REVIEW OF THE DEVICE HISTORY REVEALED NO ANOMALIES. THE EVENT SEEN BY THE CUSTOMER COULD NOT BE REPRODUCED, AND THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. POTENTIAL ROOT CAUSES INCLUDE NOT FULLY TIGHTENING THE BLUE VENT CAP AFTER GAS CALIBRATION OR AN ISSUE WITH THE CONNECTION BETWEEN THE SHUNT SENSOR AND THE TUBING. PER THE IFU, "USING STERILE TECHNIQUE, SECURELY TIGHTEN THE TOP LARGE VENTING LUER (BLUE) ON THE SHUNT SENSORS)" (AFTER GAS CALIBRATION). (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 CORPORATION THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE SHUNT SENSOR LEAKED. NO PATIENT INVOLVEMENT AS THIS EVENT OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576074 SHUNT SENSOR SYS500 DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI510H QP09C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK