BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2231795 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11585
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A CONNECTION ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE A USE ERROR; LOOSE CONNECTION. 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 WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM ON THE HOMECHOICE MACHINE (HC). DURING TROUBLESHOOTING, THE NURSE (RN) PULLED DOWN ON ALL THE TUBING AND STATED THE LINES DISCONNECTED FROM THE SOLUTION BAGS. THE RN WOULD START OVER WITH ALL NEW SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE NURSE ON (B)(6) 2011. THE NURSE STATED SHE RECEIVED A CHECK LINES AND BAGS ALARM DURING SELF TESTING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) TOLD HER TO PULL REALLY HARD ON THE LINES BY THE DOOR. THEN, THE CASSETTE PULLED APART FROM THE SOLUTION BAGS. NEW SUPPLIES WERE USED TO CLEAR THE ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 25 YR HOME CHOICE