BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2833682 · Received October 29, 2012

    Report

    Report Number
    1212122-2012-00019
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 5, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE, HOWEVER, THE COMPLAINT WAS CONFIRMED THROUGH CLINICAL REVIEW. THE RECIRCULATION LINE PRESSURE WAS 150MMHG - 200 MMHG DURING CARDIOPULMONARY BYPASS WHEN THE PERFUSIONIST DISCOVERED THE DISCONNECT. THERE WERE NO FURTHER DISCONNECTS FOR THE REMAINDER OF THE PROCEDURE. COMPLAINT WILL BE INCLUDED IN ASSOCIATES AWARENESS TRAINING. 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: "THE BLOOD LINE FROM THE QUEST CARDIOPLEGIA CAME LOOSE FROM THE 1/4 X 1/4 X 1/4 Y CONNECTOR IN OUR CUSTOM TUBING PACK. THE CUSTOMER COMPLAINED THAT THE CONNECTION SITE O.D. WAS TOO LARGE FOR THE 1/4" TUBING FROM THE QUEST CARDIOPLEGIA LINE. THEREFORE, THE LINE COULD NOT BE PUSHED FAR ENOUGH UP ONTO THE CONNECTOR." THIS OCCURRENCE OCCURRED DURING CARDIOPULMONARY BYPASS SURGERY. INTERVENTION WAS REQUIRED TO PREVENT PATIENT HARM. THE RECIRCULATION LINE WAS CLAMPED TO PREVENT FURTHER BLOOD LOSS, LINE WAS REATTACHED TO THE 1/4 CONNECTOR AND AIR WAS DE-BUBBLED PRIOR TO THE NEXT CARDIOPLEGIA DOSE. ESTIMATED BLOOD LOSS WAS 200 ML. NO TRANSFUSION PERFORMED. THERE WAS NO DELAY OR PATIENT HARM OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK. OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 70113-04 PG04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention