BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3961611 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24473
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, 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 PROVIDES INSTRUCTIONS ON HOW TO PROPERLY DISCONNECT FROM THE CYCLER DURING AN EMERGENCY AND EXPLAINS HOW TO RECONNECT FOR THERAPY AFTER PROPERLY DISCONNECTING. 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

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM OCCURRED ON THE HOMECHOICE DEVICE DURING THE INITIAL DRAIN OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT HAD DISCONNECTED FROM THE SET UP WITHOUT CLOSING THE CLAMPS. THE PATIENT THEN RECONNECTED UPON RETURNING IN ORDER TO CONTINUE THERAPY. THE POWER WAS CYCLED TO CLEAR THE ALARM. PROPER PROCEDURES WERE REVIEWED AND THE PATIENT WAS ADVISED TO START THERAPY OVER USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439363 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR HOMECHOICE