BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3120745 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12956
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IT WAS FOUND THAT THE PATIENT CONNECTED THE PATIENT LINE EXTENSION AFTER PRIMING. 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. THIS GUIDE INSTRUCTS THE USER TO CONNECT THE PATIENT LINE EXTENSION TO THE PATIENT LINE PRIOR TO PRIMING AND INSTRUCTS THE USER TO MAKE SURE THE PATIENT LINE EXTENSION IS CORRECTLY POSITIONED IN THE ORGANIZER AND VERIFY THAT THE PATIENT LINE EXTENSION IS PLACED IN THE LEFT SLOT OF THE BLUE ORGANIZER. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL OR RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER?S TECHNICAL SERVICE CENTER THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) ON THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM LOG AND THE SE 2240 WAS FOUND IN THE LOG. THE HOME PATIENT (HP) STATED THAT THEY WERE CONNECTED WHEN THE MACHINE ALARMED. THE TSR INQUIRED ABOUT HOW THE HP SET UP FOR THE THERAPY. THE HP STATED THAT THEY USED EXTENSION LINES AND CONNECTED THEM AFTER PRIME. THE TSR EXPLAINED THE ALARM AND INSTRUCTED THE HP TO START OVER WITH NEW SUPPLIES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221865 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE