BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3951234 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23734
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, IT WAS REPORTED THAT THE PATIENT DID NOT KNOW WHETHER THEY HAD PRIMED THE PATIENT LINE BEFORE CONNECTING. 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. THE GUIDE 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. IT INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY REPRIMING THE PATIENT LINE. A 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

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 ALARM (AIR IN LINE/SET). THIS EVENT OCCURRED DURING THE INITIAL DRAIN CYCLE OF PERITONEAL DIALYSIS THERAPY WHILE THE PATIENT WAS CONNECTED. THE PATIENT STATED THAT THEY DID NOT REMEMBER IF THEY HAD CHECKED THE PATIENT LINE TO VERIFY IF IT WAS PROPERLY PRIMED BEFORE CONNECTING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN CLEARING THE ALARM AND ADVISED THE PATIENT TO RESTART THERAPY WITH NEW SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427860 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