BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3200312 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16957
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 HAS INSTRUCTIONS ON THE STEPS TO PROPERLY DISCONNECT FROM CYCLER DURING AN EMERGENCY AND EXPLAINS HOW TO RECONNECT TO THERAPY AFTER PROPERLY DISCONNECTING. A LABELING REVIEW OF THE PRODUCT FAMILY WILL BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM OCCURRED ON THE HOMECHOICE (HC) MACHINE. THIS OCCURRED DURING DRAIN ONE, WHILE THE PATIENT WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HOME PATIENT (HP) STATED THAT THEY HAD DISCONNECTED AND RECONNECTED. HOWEVER, THE PROPER DISCONNECTION PROCEDURE WAS NOT USED. THE TSR ASSISTED WITH THE TROUBLESHOOTING IN ORDER TO CLEAR THE ALARM. THE TSR REVIEWED THE PROPER PROCEDURE WITH THE HP. THE HP WAS ADVISED TO DISCARD THE SUPPLIES IN ORDER TO START OVER WITH NEW SUPPLIES OR FINISH THERAPY WITH MANUAL BAGS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299673 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE