BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 615400 · Received June 1, 2005

    Report

    Report Number
    1423500-2005-00779
    Event Type
    Malfunction
    Date Received
    June 1, 2005
    Date of Event
    December 14, 2004
    Report Date
    December 14, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOME PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER FOR ASSISTANCE DURING DWELL 2/4 OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY REGARDING A SYSTEM ERROR 2240 ALARM. PER INITIAL REPORT, THE HOMECHOICE SET SUPPLY OINE SPIKE AND THE PORT OF THE SOLUTION ONTO THE NIGHTSTAND. BAXTER'S TECHNICAL SERVICE ASSISTED THE HOME PATIENT IN ENDING THERAPY EARLY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT, PER THE HOME PATIENT'S PRIMARY CARE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 31 *