BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3071561 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-10032
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HOME PATIENT (HP) IF THE FLUID WAS TO THE TOP OF THE PATIENT LINE BEFORE SHE CONNECTED, AND THE HP STATED SHE ASSUMED SO SINCE IT STATED CHECK PATIENT LINE. THE TSR EXPLAINED IT COULD NOT HAVE BEEN AND EXPLAINED THE IMPORTANCE OF MAKING SURE THAT THE FLUID WAS ALL THE WAY TO THE TOP BEFORE SHE CONNECTS AS SHE IS GIVING HERSELF AIR, AND THE HC IS DETECTING THE ERROR. THE TSR HAD THE HP CLOSE ALL THE CLAMPS AND CYCLED POWER OFF AND ON TO SE 2367. THEY CYCLED POWER OFF AND ON TO PRESS GO TO START. THE TSR ADVISED THE HP TO DISPOSE OF THE CURRENT SUPPLIES ATTACHED AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171284 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE