BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2894946 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00141
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT IS CONFIRMED BECAUSE IT WAS REPORTED DURING TROUBLE SHOOTING OF A LEAK ISSUE THAT THE CUSTOMER SWITCHED THE LEAKY SOLUTION BAG ONLY, WHICH IS A USE ERROR/POOR ASEPTIC TECHNIQUE. THE ROOT CAUSE WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER ON (B)(4) 2012 FROM A PERITONEAL DIALYSIS (PD) PATIENT THAT ON (B)(6) 2012, THERE WAS A LEAK FROM THE SOLUTION BAG TUBING; THE PATIENT SUBSTITUTED THE BAG WITH ANOTHER ONE OF THE SAME LOT AND RESUMED THERAPY. IT IS NOT KNOWN IN WHICH STEP OF THERAPY THIS HAPPENED; NO SYMPTOMS OR CONSEQUENCES WERE REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE