BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 1915706 · Received November 19, 2010

    Report

    Report Number
    9681834-2010-00035
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DXC
    PMA / PMN Number
    K070423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ALTHOUGH THERE WAS REPORTEDLY NO IMPACT TO THE PT, THE EVENT DESCRIPTION INDICATES THAT APPROXIMATELY 180-CC OR MORE OF BLOOD LOSS DID OCCUR. RESULTS: ARE BASED ON EVAL OF USER FACILITY INFO ONLY; AND BASED UPON EVAL OF THE RETAINED SAMPLE. CONCLUSION: BASED UPON EVAL OF USER FACILITY INFO ONLY; AND BASED UPON EVAL OF THE RETAINED SAMPLE. THE INVOLVED DEVICE IS NOT AVAILABLE TO BE RETURNED FROM THE USER FACILITY FOR EVAL. EVAL OF THE RETAINED SAMPLE CONFIRMED THERE WERE NO DEFECTS OR ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THE CAUSE FOR THE REPORTED DEFLATION OF THE TR BAND CANNOT BE DETERMINED BASED UPON THE AVAILABLE INFO. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS: "DO NOT INJECT MORE THAN 18ML OF AIR. THERE IS A POSSIBILITY OF DAMAGING THE DEVICE IF THIS VOLUME IS EXCEEDED;" "PT SHOULD NOT BE LEFT UNATTENDED WHILE THE TR BAND IS IN USE;" AND "DEPENDING ON THE PT'S CONDITION AND THE DEGREE OF BALLOON PRESSURE, AN ADVERSE EVENT INCLUDING ARTERY OCCLUSION, HYPODERMIC HEMATOMA, HEMORRHAGE, PAIN, OR NUMBNESS MAY OCCUR. CHECK THE PROGRESS OF THE HEMOSTASIS AND ADJUST THE AIR PRESSURE ACCORDINGLY;" AND "WHILE USING, BE CAREFUL NOT TO PUT EXCESSIVE LOAD ON THE PRESSURE CONFIRMATION BALLOON OR COMPRESSION BALLOON THAT COULD BREAK IT." ALL CURRENTLY AVAILABLE INFO HAS BEEN PLACED ON FILE BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE TR BAND "BURST" DURING USE. THE FOLLOWING INFO WAS PROVIDED BY THE USER FACILITY: THE PHYSICIAN APPLIED THE TR BAND; THE 15 MINUTE CHECKS WERE COMPLETED WITH NO PROBLEM; THE BAND APPARENTLY DEFLATED AT SOME POINT BEFORE THE FIRST 1-HOUR CHECK; THE PT WAS FOUND TO HAVE BLED APPROXIMATELY 180-CC OR MORE OF BLOOD WITH CLOTS WAS NOTED ON THE BED; TRANSFUSION WAS NOT REQUIRED; THE PT IS REPORTED TO BE "DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TR BAND DXC TERUMO CORPORATION, ASHITAKA NA 100721

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK