BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 898728 · Received October 25, 2006

    Report

    Report Number
    1718850-2006-00057
    Event Type
    Malfunction
    Date Received
    October 25, 2006
    Date of Event
    September 14, 2006
    Report Date
    September 27, 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 TUBING LISTED WAS SUPPLIED NON-STERILE BY COBE CARDIOVASCULAR, INC. TO REPORTER. REPORTER USED THE TUBING TO BUILD A HEART-LUNG PACK, WHICH WAS ALSO STERILIZED AND SUPPLIED TO THE END-USER BY REPORTER. THE CONNECTION THAT CAME APART IN THIS INCIDENT WAS MADE BY THE END-USER BETWEEN THE HEART-LUNG PACK AND A RESERVOIR MFG BY ANOTHER DEVICE MFR. SAMPLES OF THE SAME TYPE OF TUBING AND RESERVOIR WERE USED FOR TESTING. TUBING WAS CONNECTED WITHOUT TIE-BANDS AS DESCRIBED BY THE CUSTOMER 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 THERE WERE NO ISSUES WITH THE MFG DATA FOR THE TUBING AS CONTAINED IN THE DEVICE HISTORY RECORD. SINCE THIS TUBING WAS MFG, THE DIMENSIONAL CONTROL ON THE TUBING HAS BEEN HEIGHTENED. THE INSTRUCTIONS FOR USE FOR SMARXT TUBING RECOMMENDED THE USE OF TIE-BANDS. THOSE INSTRUCTIONS FOR USE HAVE BEEN RECENTLY UPDATED TO MORE CLEARLY STATE THE REQUIREMENT AND TO DEPICT THE OPTIMAL LOCATION OF A TIE-BAND. 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

    THE TUBING CONNECTED TO THE VENOUS OUTLET OF THE RESERVOIR DISCONNECTED DURING BYPASS, RESULTING IN 300-400 MLS OF BLOOD LOSS. THE TUBING WAS RECONNECTED AND A TIE-BAND WAS PLACED AROUND THE CONNECTION, IN ORDER TO COMPLETE THE CASE. THE ADD'L BLOOD WAS REPORTED TO BE DUE NOT ONLY TO THE BLOOD LOSS, BUT ALSO FOR VARIOUS OTHER CLINICAL REASONS.

    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 495832

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention