BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2120630 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07490
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER SENT IN AN ACTUAL SAMPLE FOR AN EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED FOR ANY OBVIOUS DEFECTS; THERE WERE NO VISUAL DEFECTS. EACH SAMPLE WAS ATTACHED TO AN IN-HOUSE 2C7461 SECONDARY SET SPIKED INTO A 1000ML SOLUTION BAG CONTAINING STERILE WATER. EACH SET WAS RE-PRIMED PER LABEL COPY AND CHECKED FOR LEAKS. THE SAMPLE WAS THEN UNDERWATER LEAK TESTED AND AGAIN CHECKED FOR LEAKS. THE REPORTED CONDITION WAS NOT CONFIRMED. IT IS UNKNOWN WHAT MAY HAVE CAUSED THIS CONDITION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A CLEARLINK SET IN WHICH THE SET LEAKED TOTAL PARENTERAL NUTRITION DURING SETUP WHEN IT WAS CONNECTED TO AN UNKNOWN PRIMARY SET. THE EXACT LOCATION OF THE LEAK IS AT THE FILTER; IT WAS NOTICED THAT THE FLUID WOULD BE FULLY PRIMED HOWEVER AT THE FILTER THERE WAS NO LIQUID PRESENT WHEN THE NURSES WOULD TAKE THE SET TO THEIR DESIRED LOCATION. THE TUBING BELOW THE FILTER WAS PRIMED AND THE PRIMARY SET WAS FULLY PRIMED, BUT THE FILTER CONTAINED NO FLUID. THIS CONDITION OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4 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 BAXTER HEALTHCARE R08B23034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION