BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2990371 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05311
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS CONFIRMED BECAUSE IT WAS REPORTED THAT THE PATIENT DISCONNECTED FROM THE SET DURING DRAIN. LINE DISCONNECTION (WITHOUT PROPER EMERGENCY DISCONNECT PROCEDURE) DURING THERAPY IS A KNOWN CAUSE OF SE 2240. PER THE BAXTER HOMECHOICE OPERATOR'S MANUAL, USERS ARE WARNED WITH THE CORRECT DISCONNECT PROCEDURES. THE ASSIGNABLE CAUSE IS USE ERROR-PATIENT DISCONNECTED FROM THE SET. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) DURING DRAIN 1 OF 5 ON THE HOME CHOICE (HC). THE CAREGIVER (CG) STATED THE HOME PATIENT (HP) DISCONNECTED DURING DRAIN AND RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND INSTRUCTED THE CG TO CYCLE POWER, THE HC THEN ALARMED SE 2367. THE CG WAS TO RESTART WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93351 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE