BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3240295 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19274
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A HOME PATIENT (HP) RECEIVED A SYSTEM ERROR (SE) 2240 (AIR IN LINE) WITH A CASCADING SE 2367 ALARM ON THE HOMECHOICE (HC) WHILE CONNECTED WITH AN HC AUTOMATED PD SET WITH CASSETTE DURING DWELL 2 OF 4. DURING TROUBLESHOOTING WITH THE TECHNICAL SERVICE REPRESENTATIVE (TSR), THERE WERE NO OPEN CLAMPS OR UNUSED SUPPLY LINES, THE LINES HAD BEEN PROPERLY PRIMED BEFORE CONNECTING AND THE PATIENT DID NOT DISCONNECT PRIOR TO THE ALARM, THE PATIENT EXTENSION LINES WERE NOT BEING USED AND BAGS WERE PROPERLY CONNECTED. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE PATIENT AND ASSISTED THE PATIENT TO START OVER THERAPY WITH NEW SUPPLIES. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341431 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE