BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET

    MDR report key: 1973860 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01294
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF THIS PERITONITIS EPISODE IS UNKNOWN, AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION. THIS IS REPORT 4 OF 5 ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10J28017 AND H10J21061 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE HAS BEEN DETERMINED AS POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE FOURTH OF FIVE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    DURING A CALL TO BAXTER REGARDING A UNRELATED ALARM, THE CAREGIVER FOR THE HOME PATIENT(HP) STATED THAT THE HP WAS ON ANTIBIOTICS FOR PERITONITIS. ON (B)(6) 2011, BAXTER CONTACTED THE HP'S DIALYSIS NURSE (PDRN) WHO STATED, ON (B)(6) 2010 THE HP REPORTED CLOUDY PERITONEAL EFFLUENT AND WAS INSTRUCTED TO COME TO THE DIALYSIS CLINIC. THAT DAY, CULTURES OF THE PD EFFLUENT WERE OBTAINED. TREATMENT STARTED IMMEDIATELY WITH INTRAPERITONEAL (IP) ANCEF 2GM DAILY FOR 4 WEEKS. THE HP HAS PERFORMED NIGHTLY PD THERAPY WITH THE HOME CHOICE AND LOCAL (PD4) AMBUFLEX SOLUTION FOR AN UNREPORTED PERIOD OF TIME, AND CONTINUES THIS REGIME TO DATE. THE LAST DOSE OF THE 4 WEEK ANCEF IP TREATMENT WAS (B)(6) 2011. THE PDRN ADDED THAT THE HP HAS RECOVERED, HOWEVER A RECULTURE HAS NOT YET BEEN COMPLETED. CAUSALITY GIVEN BY THE PDRN WAS PROBABLE TOUCH CONTAMINATION DUE TO THE NATURE OF THE ORGANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 FOOT EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LOCAL (PD4) AMBUFLEX| HOME CHOICE CYCLER