BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073310 · Received May 1, 2011

    Report

    Report Number
    1423500-2011-05235
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A PATIENT WHO DISCONNECTED BEFORE THERAPY WAS OVER WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, CAUSE OF THE USE ERROR IS UNDETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE WITH ENDING THERAPY ON THE HOMECHOICE (HC) SYSTEM DURING DRAIN 1, BECAUSE THE HOME PATIENT (HP) HAD REPORTEDLY DISCONNECTED HERSELF DURING THE DRAIN CYCLE. THE CAREGIVER (CG) WANTED TO END THE THERAPY AND RESTART SETUP WITH ALL NEW SUPPLIES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH ENDING THE THERAPY AND RESTARTING SETUP USING ALL NEW SUPPLIES. 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 HP REGARDING THE USE ERROR, THE HP DENIED HAVING HAD DISCONNECTED DURING DRAIN OR HAVING ANY PROBLEM WITH THERAPY. PER HP, SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ANY ISSUES. THE HP CONFIRMED THAT SHE IS AWARE OF PROPER PROCEDURES, AND THAT SHE KNOWS NOT TO DISCONNECT DURING A DRAIN CYCLE. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP?S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR HC CYCLER