BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2892527 · Received January 2, 2013

    Report

    Report Number
    1416980-2013-00011
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE DEVICE USED IN REPORTED CONDITION IS UNKNOWN; THEREFORE, A US 510K NUMBER CANNOT BE PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF AN UNKNOWN BAXTER ADMINISTRATION SET IN WHICH THE NURSE OBSERVED LEAKAGE OF A TOTAL PARENTERAL NUTRITION (TPN) SOLUTION AFTER THE INFUSION STARTED. THE SET WAS BEING USED WITH COLLEAGUE INFUSION PUMP. WHEN THE TUBING WAS UNLOADED, IT WAS NOTICED THAT THE TUBING WAS "CHEWED AND PUNCTURED". A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 TPN, COLLEAGUE PUMP