BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3833806 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17095
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, THE HOME PATIENT (HP) REPORTED DISCONNECTING THE HEATER BAG AND RECONNECTING IT TO THE CASSETTE LINE. USE ERROR 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. THE GUIDE WARNS THE USER NOT TO REPLACE EMPTY SOLUTION BAGS OR RECONNECT DISCONNECTED SOLUTION BAGS DURING THERAPY. IT ALSO WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING FOR A CHECK SUPPLY LINE ALARM, A HOME PATIENT (HP) REPORTED TRYING TO DISCONNECT AND RECONNECT THE HEATER BAG IN AN ATTEMPT TO CLEAR THE ALARM. THE EVENT OCCURRED DURING AUTOMATED PERITONEAL DIALYSIS (APD) USING A HOMECHOICE (HC) DEVICE. A TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED PROPER PROCEDURES TO THE HP, AND INSTRUCTED THE HP TO EITHER RESTART THERAPY USING NEW SUPPLIES OR COMPLETE THERAPY USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311398 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOMECHOICE