BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2120206 · Received June 6, 2011

    Report

    Report Number
    1212122-2011-00106
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND THE COMPLAINT WAS CONFIRMED. THIS IS A CUSTOMER MADE CONNECTION WHICH WAS NOT TIE-BANDED BY THE USER. THE SAMPLE WAS NOT PUSHED OVER THE SECOND BARB. TERUMO CARDIOVASCULAR SYSTEMS' CARDIOVASCULAR PROCEDURE KIT INSTRUCTIONS FOR USE RECOMMENDS TIE-BANDING ALL CONNECTIONS TO PREVENT DISCONNECTS. NO LEAKS WERE FOUND THROUGH PRESSURE TESTING, WHICH SUGGESTS THAT THE LEAK OCCURRED DUE TO CUSTOMER TECHNIQUE. TERUMO WILL REFERENCE PROPER CONNECTION TECHNIQUES TO THE CUSTOMER. ALL USER MADE CONNECTIONS SHOULD BE TIE-BANDED, AND TUBING SHOULD BE PUSHED OVER THE SECOND BARB. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATE 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 F/U. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY, THE CARDIOPLEGIA LINE THAT COMES OFF THE RECIRCULATION LINE THAT IS CONNECTED TO THE Y-CONNECTOR DISCONNECTED. THE PRODUCT WAS NOT CHANGED OUT, THERE WAS ABOUT 300 CC'S OF BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE. INTERVENTION WAS REQUIRED TO RE-CONNECT THE TUBING, RE-PRIME, AND DE-BUBBLE THE CARDIOPLEGIA KIT. 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 ND07

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention