BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 414571 · Received August 30, 2002

    Report

    Report Number
    1423500-2002-01111
    Event Type
    Malfunction
    Date Received
    August 30, 2002
    Date of Event
    August 19, 2002
    Report Date
    August 28, 2002
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A HOME PATIENT REPORTED THAT WHILE SETTING UP SUPPLIES FOR A HOME PATIENT'S AUTOMATED PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE MACHINE EXPERIENCED TROUBLE CONNECTING A SUPPLY BAG TO THE SUPPLY LINE OF THE HOMECHOICE SET. THE HOME PATIENT TRIED SEVERAL TIMES TO CONNECT A SUPPLY BAG, BUT WAS ONLY ABLE TO GET THE SPIKE PARTIALLY THROUGH THE MEMBRANE OF THE BAG. THE HOME PATIENT THEN DISCONNECTED THAT SUPPLY BAG FROM THE SUPPLY LINE OF THE HOMECHOICE SET, AND CONNECTED A NEW SUPPLY BAG TO THAT SUPPLY LINE WITH NO FURTHER TROUBLE. PER THE HOME PATIENT, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT.

    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 UNKNOWN (REFURBISHED).| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT