BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2081661 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03788
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT CONTAIN A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THREE UNUSED SAMPLES AND ONE USED SAMPLE FOR EVALUATION. ALL THE SETS WERE TESTED UNDER WATER FOR LEAKAGE AT 0.56 BAR OF AIR PRESSURE, AND NO LEAK WAS OBSERVED FOR ALL THE SAMPLES TESTED. THEREFORE, THE REPORTED DEFECT WAS NOT CONFIRMED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A REPORT RECEIVED BY BAXTER (B)(4) ON (B)(6) 2011 REGARDING THE SPIKE WITH CLEARLINK INJECTION SITE. THE CUSTOMER REMOVES THE SPIKE WITH CLEARLINK INJECTION SITE FROM THE OVERPOUCH, AND IT IS CONNECTED TO A SET OF TUBES. THIS IS THEN PUT BACK INTO THE OVERPOUCH AND STERILIZED WITH GAS. THIS PROCESS HAS BEEN REPEATED FOR A LONG TIME WITHOUT SUFFERING ANY PROBLEMS. THE CUSTOMER COMPLAINS THAT AIR BUBBLES ARE FORMED. THE SET IS USED AT FLOW RATE UP TO 300ML/MIN. NACL IS USED, AND CONTINUED WITH A VACUUM IN ORDER TO SQUEEZE THE FAT TISSUE. THIS ALLOWS THE FAT TO BECOME MORE LOOSE AND MAKES EASIER THE SUCTION OF SUPERFLUOUS POUNDS. WHEN THE FLOW RATE REACHES 100ML/MIN, A MASSIVE AMOUNT OF AIR BUBBLES ENTER THE SYSTEM. THIS INDICATES THERE IS A LEAK IN THE CLEARLINK OR THE CONNECTION OF THE TUBING. THIS IS REPORT 3 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 08E15V346

    Patients

    Seq Age Sex Outcome Treatment
    1 SET, NACL