BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2123018 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07603
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED. THE CAUSE IS THAT THE PATIENT DID NOT PLACE THE SOLUTION BAG ON A FLAT, STABLE SURFACE. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT A BAG FELL OFF DURING DWELL 2 ON THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP)'S NURSE WANTED TO START OVER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE NURSE TO END THERAPY SO THEY COULD START OVER WITH NEW SUPPLIES. IT WAS UNKNOWN HOW THE SECOND BAG FELL OFF. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HEAD NURSE REGARDING THE DISCONNECTION OF THE BAG, IT WAS REVEALED THAT THE BAG FELL OFF THE TRAY AND THE NURSE THOUGHT THAT IT WAS NOT STABLE ON THE TRAY. PER NURSE, WHEN THE BAG FELL ON THE FLOOR, THE SPIKE FELL OUT. THE NURSE STATED THEY STARTED OVER WITH NEW SUPPLIES AND THE HP RESUMED THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE