BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBG, PVC W/SMA, 3/8 X 3/32

    MDR report key: 841849 · Received October 12, 2006

    Report

    Report Number
    1718850-2006-00055
    Event Type
    Malfunction
    Date Received
    October 12, 2006
    Date of Event
    August 31, 2006
    Report Date
    September 11, 2006
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG DATE LISTED IS FOR THE TUBING ITSELF. FACILITY REPORTED THAT THE HEART-LUNG PACK WAS MANUFACTURED IN MARCH 2006. THE TUBING LISTED IN SECTION D WAS SUPPLIED NON-STERILE BY COBE CARDIOVASCULAR, INC. TO FACILITY. THE FACILITY USED THE TUBING TO BUILD A HEART-LUNG PACK, WHICH WAS ALSO STERILIZED AND SUPPLIED TO THE END-USER BY THE FACILITY. THE CONNECTION THAT CAME APART IN THIS INCIDENT WAS MADE BY THE END-USER BETWEEN THE HEART-LUNG PACK AND A RESERVOIR MANUFACTURED BY ANOTHER DEVICE MANUFACTURED. SAMPLES OF THE SAME TYPE OF TUBING AND RESERVOIR WERE USED FOR TESTING. TUBING WAS CONNECTED WITHOUT TIE-BANDS (MORE WORSE CASE THAN THE CUSTOMER CONNECTION AT THE TIME OF THE ISSUE) AND WEIGHTED DOWN OVER A PERIOD OF 7 DAYS. THE TUBING DID NOT SLIP OR DISCONNECT. THE TUBING INVOLVED IN THIS ISSUE WAS NOT RETURNED FOR ANALYSIS, AND TEHRE WERE NO ISSUES WITH THE MFG DATA FOR THE TUBING AS CONTAINED IN THE DEVICE HISTORY RECORD. SINCE THIS TUBING WAS MANUFACTURED, THE DIMENSIONAL CONTROL ON THE TUBING HAS BEEN HEIGHTENED AND THE INSTRUCTIONS FOR USE HAVE BEEN UPDATED TO DEPICT THE OPTIMAL LOCATION OF A TIE-BAND. HOWEVER, SINCE THE CAUSE FOR THIS INCIDENT CAN NOT BE DETERMINED, IT IS UNKNOWN WHETHER THESE IMPROVEMENT STEPS ARE RELEVANT.

    Description of Event or Problem · 1

    APPROX 54 MINUTES INTO BYPASS, THE TUBING DISCONNECTED FROM THE VENOUS OUTLET OF THE RESERVOIR RESULTING IN LOSS OF BLOOD VOLUME FROM THE RESERVOIR (APPX 500 MLS) AND CESSATION OF SUPPORT FOR JUST UNDER FOUR MINUTES AT 32 DEGREE C. THE PT REQUIRED BLOOD TRANSFUSION TO MAKE UP FOR THE VOLUME LOSS AND RESTITUTION OF CPB CIRCUIT. THERE WAS NO PT DETRIMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBG, PVC W/SMA, 3/8 X 3/32 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE COBE CARDIOVASCULAR, INC. NA 487317

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention