BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3884946 · Received June 19, 2014

    Report

    Report Number
    1416980-2014-19514
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE ¿HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE, PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND SAYS TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. THE GUIDE ALSO PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY LOADING THE DISPOSABLE SET, AND INSTRUCTS THE USER TO CLOSE ALL CLAMPS ON THE DISPOSABLE SET PRIOR TO WHEN THE HOMECHOICE DISPLAYS LOAD THE SET. DRAIN LINE CLAMPS ARE OPENED AFTER ATTACHING THE DRAIN OPTION AND CLAMPS FOR LINES CONNECTED TO SOLUTION BAGS ARE OPENED RIGHT BEFORE PRIMING. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING FOR A CHECK LINES AND BAGS ALARM ON A HOMECHOICE (HC) DEVICE, A TECHNICAL SERVICE REPRESENTATIVE (TSR) DISCOVERED THAT A HOME PATIENT (HP) CONNECTED TO THE HC CASSETTE PRIOR TO ALLOWING THE PATIENT LINE TO PRIME PROPERLY. THE HP INDICATED THAT THE CLAMP ON THE HEATER LINE HAD BEEN CLOSED. THE TSR EXPLAINED PROPER PROCEDURES WITH THE HP AND INSTRUCTED THE HP TO RESTART THERAPY USING NEW SUPPLIES. 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
    359603 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HOMECHOICE