BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2991437 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05420
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE EVENT WAS USE ERROR. THE LABELING IS SUFFICIENT IN INSTRUCTING THE PATIENT HOW TO PROPERLY DISCONNECT. THERE WAS NO REPORTED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AR 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 AND NO PATIENT EXTENSIONS WERE IN USE. THE HOME PATIENT (HP) SAID THAT SHE HAD DISCONNECTED BUT DID NOT USE PROPER PROCEDURES. THE HP HAD THEN RECONNECTED. THE BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER OFF AND ON, AND THE HC ALARMED SYSTEM ERROR 2367. THE HP CYCLED THE POWER AGAIN, AND THE SYSTEM ERRORS DID NOT REPEAT. THE HC WAS AT "PRESS GO TO START." THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95929 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR HOMECHOICE