BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 2111188 · Received May 26, 2011

    Report

    Report Number
    1124841-2011-00234
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 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 DID NOT RECEIVE THE ACTUAL DEVICE FOR EVAL, THE EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. THERE WAS NO LOT NUMBER PROVIDED, THE DESIGN HISTORY FILE COULD NOT BE REVIEWED. UNCONTROLLED ENVIRONMENT, INCORRECT CALIBRATION, OR IMPROPER PRIMING SOLUTION MAY HAVE CAUSED THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS SURGERY, A CO2 SENSOR ERROR WAS DISPLAYED ON THE MONITOR. THE PRODUCT WAS CHANGED OUT. THERE WAS APPROX 1 CC 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. CDI510H UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK