BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1894890 · Received November 8, 2010

    Report

    Report Number
    1124841-2010-00200
    Date Received
    November 8, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. TERUMO WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY IT WAS OBSERVED THAT MORE THAN THE TYPICAL AMOUNT OF AIR WAS NOTED IN THE CORONARY ARTERIES. THE USER FACILITY SUGGESTED THAT THE CAUSE MAY HAVE BEEN A DEFECTIVE VALVE, WHICH WAS NOT VENTING THE AIR PROPERLY. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO BLOOD LOSS. THERE WAS A DELAY OF 5 MINUTES DURING THE EXTENDED PERFUSION AT HIGHER FLOWS AND PRESSURE. THERE WAS NO OBSERVED PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA MF03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK