BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2242179 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12030
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 21, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - FAILED TO FOLLOW THERAPY STEPS WAS CONFIRMED AND THE CAUSE WAS USE ERROR - PATIENT SWITCHED THE HEATER BAG ONLY AND REUSED THE DISPOSABLE SET. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT AND LOT NUMBER IS UNKNOWN.THE SAMPLE IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THIS REPORT IS FOR USE ERROR- PATIENT REMOVED THE EMPTY HEATER BAG AND REPLACED IT WITH A NEW ONE DURING THERAPY. THE REGISTERED NURSE(RN) REPORTED THAT THE HOME PATIENT HAD REMOVED THE EMPTY HEATER BAG AND REPLACED IT WITH A NEW ONE AND WAS ABLE TO COMPLETE THERAPY. THE TSR EXPLAINED TO RN THIS WAS POTENTIALLY CONTAMINATED THE SET UP. THE RN UNDERSTOOD. THE RN WILL FOLLOW UP WITH THE HP AND ADVISE THE HP TO CALL FOR ASSISTANCE WHEN THE ALARM OCCURS AND NOT TO TRY TO FIX IT HERSELF. THE RN WILL ADVISE THE HP OF POTENTIAL CONTAMINATION AND POSSIBLY PRESCRIBE ANTIBIOTICS. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1