BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 1890685 · Received November 1, 2010

    Report

    Report Number
    1124841-2010-00183
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 12, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE SHUNT SENSOR LEAKED. THE PRODUCT WAS CHANGED OUT AND 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 CORPORATION CDI510H MG18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK