BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2091754 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04143
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THE LOT NUMBER IS INCORRECT.

    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 MICRON EXTENSION SET IN WHICH THE FEMALE LUER OF THE EXTENSION SET WAS LEAKING DUE TO A BROKEN LUER. THIS CONDITION OCCURRED WHILE PRIMING WITH TOTAL PARENTERAL NUTRITION AND D10 DEXTROSE. AN ALARIS PRIMARY SET WAS USED WITH THIS EXTENSION SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. THE SAMPLES ARE NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 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

    Patients

    Seq Age Sex Outcome Treatment
    1 ALARIS PRIMARY SET| TOTAL PARENTERAL NUTRITION AND D10 DEXTROSE