BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 3252218 · Received July 25, 2013

    Report

    Report Number
    1212122-2013-00008
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 3, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 DISCUSSION AND REVIEW. 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 FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    OUR END USER HAS REPORTED THE "TUBING SLIPPED OFF CONNECTOR. VENT LINE TO PUMP PACK." CLINICAL DISCUSSION: THERE WAS A DISCONNECTION OF A VENT/SUCKER LINE DURING CPB. A 1/4" ID LINE FROM THE TABLE PACK IS HANDED DOWN TO THE PERFUSIONIST, WHO CONNECT THE LINE TO A 1/4" CONNECTOR THAT IS PART OF A LINE IN THE PUMP PACK. THE DISCONNECTION OCCURRED DURING CPB AND THE BLOOD LOSS WAS ESTIMATED TO BE 100 ML. THE LINE WAS RECONNECTED AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS DELAYED THE VENTING PROCESS BY 5 MINUTES, BUT DID NOT DELAY THE ACTUAL SURGICAL PROCEDURE. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347546 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK DWF TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 74696 QF06TC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention