BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3240259 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19273
    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
    TX, 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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN SET), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 1 OF 2, WHILE THE PATIENT WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE THE POWER TO SE 2367. THEN THE TSR HAD THE HP CYCLE THE POWER TO PRESS GO TO START AND HAD THE HP DISCONNECT AND REMOVE THE CASSETTE. THE TSR ASSISTED THE HP TO CLEAR ALARMS AND ADVISED TO CONTACT THE REGISTERED NURSE (RN). 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
    341122 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