BEUDAMED
    FDA Adverse Event Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 2021920 · Received March 7, 2011

    Report

    Report Number
    1124841-2011-00101
    Date Received
    March 7, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 21, 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
    BE
    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 DURING A PROCEDURE OTHER THAN CARDIOPULMONARY BYPASS, THE SHUNT SENSOR WOULD NOT ALLOW GAS FLOW. THE PRODUCT WAS CHANGED OUT. IT IS UNK WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY OR WITHOUT 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 CORP. CDI510H ML02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK