BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3922819 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21917
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, IMPROPERLY DISCONNECTING FROM THE SET IS A KNOWN CAUSE OF THIS ALARM. 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 REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD THE DEVICE BE RETURNED OR 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 DRAIN CYCLE ONE OF THREE OF PERITONEAL DIALYSIS THERAPY WHILE THE PATIENT WAS CONNECTED. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD DISCONNECTED FROM THE SET WITHOUT USING PROPER DISCONNECT PROCEDURES. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT IN CLEARING THE ALARM AND ADVISED THE PATIENT TO RESTART THERAPY WITH NEW SUPPLIES. 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
    399720 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR HOMECHOICE