BEUDAMED
    FDA Adverse Event Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 2112494 · Received April 4, 2011

    Report

    Report Number
    1124841-2011-00159
    Date Received
    April 4, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 18, 2011
    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 HAS RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION; HOWEVER THE INVESTIGATION IS NOT YET COMPLETE. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    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. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS 1CC OF BLOOD LOSS. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP CDI1510H UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK