BEUDAMED
    FDA Adverse Event Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 1994430 · Received February 3, 2011

    Report

    Report Number
    1124841-2011-00055
    Date Received
    February 3, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 2, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT REC'D THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    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. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY AND W/O DELAY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI510H MH20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK