BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 3001429 · Received March 7, 2013

    Report

    Report Number
    1212122-2013-00003
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND IT WAS EVALUATED. A VISUAL INSPECTION DID NOT NOTE ANY DISCREPANCIES WITH THE TUBING OR CONNECTOR. BOTH WERE DIMENSIONALLY EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. IT WAS REPORTED THAT THIS CONNECTION WAS NOT TIE BANDED BY THE USER, AS STATED IN THE CARDIOVASCULAR PROCEDURE KIT INSTRUCTIONS FOR USE, "PUSHING USER MADE CONNECTIONS PAST THE SECOND BARB AND TIE-BANDING ALL USER MADE CONNECTIONS WILL PREVENT DISCONNECTION AND LEAKS." TERUMO WILL MONITOR FOR FUTURE ISSUES. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATES AWARENESS TRAINING. THE DEVICE HISTORY 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

    IT WAS REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CPB, THE TUBING SLIPPED OFF THE Y CONNECTOR RESULTING IN 175 - 200 ML OF BLOOD LOSS. THE FOLLOWING EVENT INFORMATION WAS GATHERED THROUGH CLINICAL DISCUSSION. THIS EVENT OCCURRED DURING AN ELECTIVE CONGENITAL REPAIR WHERE TWO SEPARATE VENOUS CANNULAE WERE USED WITH A 1/4 SINGLE STERILE CONNECTOR AND THE CONNECTIONS WERE MADE BY THE SURGICAL TEAM. THIS DISCONNECT OCCURRED WHILE THE PT'S TEMPERATURE WAS AT 28 DEGREES C. THE VENOUS LINE THAT RETURNS BLOOD TO THE VENOUS RESERVOIR DISCONNECTED FROM THE Y CONNECTOR. THIS WAS QUICKLY IDENTIFIED BY THE SURGICAL TEAM, AND THE VENOUS LINE TUBING WAS RECONNECTED WITHOUT NEED OF TEMPORARILY WEANING FROM CPB. THE PT DID REQUIRE A TRANSFUSION OF 150 ML OF RED BLOOD CELLS TO COMPENSATE FOR THE BLOOD LOSS. THE PROCEDURE WAS COMPLETED, AS SCHEDULED, BUT IT DID PROLONG THE AORTIC CROSS-CLAMP PERIOD AND DELAYED THE CONTINUATION OF THE PROCEDURE ABOUT 5 MINUTES. THE PT WAS WEANED FROM CPB WITHOUT ISSUE. THERE WAS NO HARM OBSERVED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97260 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 70779 PA23

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Required Intervention