BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 408201 · Received July 24, 2002

    Report

    Report Number
    1423500-2002-00917
    Event Type
    Malfunction
    Date Received
    July 24, 2002
    Date of Event
    July 16, 2002
    Report Date
    July 16, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A HOME PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER FOR ASSISTANCE REGARDING A SYSTEM ERROR 2240 MESSAGE THAT APPEARED ON THE DISPLAY OF THE HOME PATIENT'S HOMECHOICE MACHINE DURING DWELL 1/4 OF THE AUTOMATED PERITONEAL DIALYSIS THERAPY. REPORTEDLY, DURING SETUP THE HOME PATIENT HAD INADVERTENTLY CONNECTED A SUPPLY BAG TO THE FINAL LINE OF THE HOMECHOICE SET RATHER THAN THE APPROPRIATE SUPPLY LINE. AFTER NOTING THIS THE HOME PATIENT, DISCONNECTED THE SUPPLY BAG FROM THE FINAL LINE, AND CONNECTED THAT BAG TO A SUPPLY LINE OF THE HOMECHOICE SET. IN DOING THIS THE HOME PATIENT LEFT THE FINAL LINE UNCLAMPED WITH NO TIP PROTECTOR IN PLACE. BAXTER'S TECHNICAL SERVICE CENTER ASSISTED THE HOME PATIENT IN ENDING THE THERAPY EARLY. 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 INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN (REFURBISHED).| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT