BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSSETT 4-PRONG

    MDR report key: 347131 · Received August 10, 2001

    Report

    Report Number
    1423500-2001-01194
    Event Type
    Malfunction
    Date Received
    August 10, 2001
    Date of Event
    July 10, 2001
    Report Date
    July 19, 2001
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER FRANCE REPORTED "DIALYSATE LEAK AT THE HOMECHOICE DOOR LEVEL". PER BAXTER FRANCE, THE PATIENT DISCONTINUED TREATMENT AND RESET WITH NEW SUPPLIES AT THE TIME LEAK WAS NOTED. PER BAXTER FRANCE, NO PATIENT INJURY OR MEDIAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36333 HOMECHOICE AUTOMATED PD SET W/CASSSETT 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE PTE. LTD. NA S01C3003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN