BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3173455 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15599
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPB
    PMA / PMN Number
    K113227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILTER OF A 3 LEAD EXTENSION SET WITH 0.22 MICRON AIR ELIMINATING FILTER BECAME DISCOLORED (TURNING EITHER BROWN OR BLACK) AND THAT THE EXTENSION SET HAD A "BLACKISH STREAK" IN IT. THIS OCCURRED DURING PATIENT INFUSION OF TOTAL PARENTERAL NUTRITION. THE LINE WAS INTERRUPTED AND THE EXTENSION SET WAS CHANGED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. REPORT FOUR OF SIX. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273342 ACCESS FILTER, INFUSION LINE FPB BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PARENTERAL NUTRITION