BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 3163008 · Received May 9, 2013

    Report

    Report Number
    1212122-2013-00005
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 RAW MATERIAL INSPECTION RECORDS FOR THE 1/2X1/2 CONNECTOR WERE REVIEWED AND NO ABNORMALITIES WERE FOUND. [THIS CUSTOMER CONNECTION WAS SAID TO BE MADE PER IFU PER THE USER.] COMPLAINT WILL BE INCLUDED IN ASSOCIATES AWARENESS TRAINING. THE DEVICE HISTORY DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND F/U. NOTES: (B)(4).

    Description of Event or Problem · 1

    PERFUSIONIST WAS ON BYPASS AND THE VENOUS LINE CAME OUT THE VENOUS INLET OF THE OXYGENATOR. CLINICAL DISCUSSION: THE CUSTOMER CONNECTS LINE 26 OF THE PRINT TO THE VENOUS INLET CONNECTOR OF THE CVR. A [SUPPLEMENTAL ACCESSORY] CDI CUVETTE ASSEMBLY (PART # 6932) CONNECTS TO LINE 26 [OF CARDIOVASCULAR PROCEDURE KIT 70334-03]. THIS CONNECTION WAS PUSHED PAST THE SECOND BARB AND TIE BANDED. THE LINE SEPARATION OCCURRED BETWEEN THE 0.5" - 0.5" CONNECTOR OF LINE 26 AND THE CDI 6932 TUBING. THIS OCCURRED DURING CPB AND RESULTED IN A BLOOD LOSS OF ABOUT 600 ML. AFTER IDENTIFYING THE ISSUE, THE CUSTOMER STOPPED THE ARTERIAL PUMP AND RE-CONNECTED 6932 BACK TO THE CONNECTOR OF LINE 26. THE TIME OFF CPB WAS ABOUT 20 SECONDS. AFTER THE TUBING WAS RE-CONNECTED, CPB WAS RE-INITIATED AND THE REMAINDER OF THE PROCEDURE WAS WITHOUT ISSUE. THE PT DID NOT REQUIRE A BLOOD TRANSFUSION AND THE TOTAL DELAY WAS ABOUT 30 SECONDS. THERE WERE NO SIGNS OF HARM DURING THE PROCEDURE OR LATER IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202822 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 70334-03 PM29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention