BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2152566 · Received June 27, 2011

    Report

    Report Number
    1212122-2011-00116
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND FURTHER INVESTIGATION IS NECESSARY. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. NOTE: ALL BLANK SECTIONS INDICATE UNK DATA OR INFO NOT APPLICABLE TO THIS SUBMISSION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY, BLOOD LEAKED IN THE COLDER CONNECTOR (QUICK DISCONNECT). THE PRODUCT WAS NOT CHANGED OUT, THERE WAS 3 CC'S BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ND14T

    Patients

    Seq Age Sex Outcome Treatment
    1