BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3180594 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16019
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERITONEAL DIALYSIS (PD) THERAPY, A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING DWELL 3 OF 4. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE HOME PATIENT (HP) TO CLEAR THE ERROR AND INFORMED THE HP OF THE ERROR'S MEANING. THE HP STATED THAT THERE WERE NO LEAKS OR DISCONNECTIONS ON THE SETUP. THE SUPPLY BAG WAS EMPTY AND THE HEATER BAG STILL HAD FLUID IN THE DWELL 3 OF 4. THE HP WOULD COMPLETE THERAPY WITH A MANUAL EXCHANGE. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279674 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HOMECHOICE