BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1735476 · Received June 17, 2010

    Report

    Report Number
    1212122-2010-00017
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO TERUMO THAT THE BLUE PRESSURE RELIEF VALVES IN THE PACK WERE MISSING, TERUMO WAS UNABLE TO CONFIRM DUE TO THE DEVICE NOT BEING RETURNED. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS LOT. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS PROCEDURE, THE BLUE PRESSURE RELIEF VALVES FOR THE PACK WERE MISSING. THERE WAS NO BLOOD LOSS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA MD29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK