BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 731117 · Received June 20, 2006

    Report

    Report Number
    1423500-2006-00710
    Event Type
    Malfunction
    Date Received
    June 20, 2006
    Date of Event
    May 23, 2006
    Report Date
    May 23, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A HOME PATIENT (HP), USING A HOMECHOICE SYSTEM (HC) CONTACTED BAXTER TECHNICAL SERVICE, REPORTED SEEING FLUID LEAKING THAT OCCURRED DURING FILL 1. HP REQUESTS HELP ENDING THERAPY, WAS CONNECTED AT TIME TO LEAK AND NO ALARMS WERE REPORTED. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED HP WITH ENDING THE THERAPY EARLY. THERAPY WAS COMPLETED BY SETTING UP WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT PER THE HOME PATIENT'S SPOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 15 LITER DRAINAGE BAGS| CAPD TRANSFER SET| DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK)| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT