BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2903406 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00579
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR - OPEN CLAMP. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 1. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING. NO PATIENT EXTENSION LINES WERE IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. ALL OF THE BAGS WERE PROPERLY CONNECTED. THE SUPPLIES HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE HOME PATIENT (HP) CHECKED THE LINES AND BAGS AND FOUND THAT THE UNUSED THE SUPPLY LINE CLAMP WAS OPEN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER SETUP PROCEDURE. THE HP CYCLED THE POWER TO CLEAR THE SYSTEM ERROR 2240 WHICH WAS THEN FOLLOWED BY A SYSTEM ERROR 2367. THE HP THEN ENDED THERAPY. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVE THE CASSETTE. THE HP WAS TO NOTIFY HER PERITONEAL DIALYSIS REGISTERED NURSE AND START OVER WITH NEW SUPPLIES. PROPER PROCEDURES WERE REVIEWED. THERE WERE NO SAMPLES OR LOT NUMBERS AVAILABLE. 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
    12085 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