BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2051497 · Received April 4, 2011

    Report

    Report Number
    1212122-2011-00082
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE AND FURTHER INVESTIGATION IS NECESSARY. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, OUT-OF-BOX, THE DUROMETER OF TUBING WAS SOFTER THAN NORMAL. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION MN16

    Patients

    Seq Age Sex Outcome Treatment
    1