BEUDAMED
    FDA Adverse Event Summary report: N

    SHUNT SENSOR SYS500

    MDR report key: 1994433 · Received February 4, 2011

    Report

    Report Number
    1124841-2011-00057
    Date Received
    February 4, 2011
    Date of Event
    January 25, 2011
    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 RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. 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 PROBLEM OCCURRED TWO TIMES; HOWEVER, EVENT INFORMATION WAS ONLY PROVIDED FOR ONE OCCURRENCE. THE PRODUCT WAS CHANGED OUT. THERE WAS NO DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS LESS THAN 1CC OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI510H MM12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK