BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1961508 · Received January 10, 2011

    Report

    Report Number
    1212122-2011-00007
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 24, 2010
    Report Date
    December 16, 2010
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; HOWEVER, 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, DURING PRIME, THE HEAT EXCHANGER WOULD NOT HOLD VOLUME. THE CUSTOMER SUSPECTED THAT THE OVER-PRESSURIZATION LINE WAS INCOMPETENT AND LEAKED THE VOLUME INTO THE CARDIOTOMY. THE PRODUCT WAS CHANGED OUT, THERE WAS NO BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO 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 MM04

    Patients

    Seq Age Sex Outcome Treatment
    1