BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3130703 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13450
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 12, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE WAS DETERMINED TO BE USE ERROR DUE TO THE PATIENT LEAVING THE PATIENT LINE CLAMPED DURING PRIME AND STARTING THERAPY WITH AN IMPROPERLY PRIMED PATIENT LINE. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE", WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. SECTION 10-8 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. PAGE 3-2 WARNS THE USER NOT TO CONNECT TO YOUR PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. PAGE 10-21 INFORMS THE USER TO OPEN CLAMPS ON LINES CONNECTED TO SOLUTION BAGS AND THE PATIENT LINE TO ENSURE PROPER PRIMING. USERS ARE NOT INSTRUCTED TO CLOSE THE PATIENT LINE CLAMP ANYTIME DURING THERAPY UNLESS FOR AN EMERGENCY DISCONNECT PROCEDURE (SECTION 15.10). PAGE 10-22 INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. SECTION 15.7 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY REPRIMING THE PATIENT LINE. THIS REVIEW FOUND THE LABELING ACCESSIBLE, ACCURATE, AND ADEQUATE FOR THE RELATED USE ERROR FOUND IN THIS COMPLAINT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING PERITONEAL DIALYSIS, A HOME PATIENT (HP) RECEIVED A SYSTEM ERROR 2240 (AIR IN SET) ALARM ON A HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE PATIENT LINE WAS NOT PROPERLY PRIMED DUE TO THE PATIENT LINE BEING CLAMPED DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG) IN CLEARING THE ALARM. THE CG SET UP THE HP WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230807 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR HOMECHOICE