BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 479987 · Received August 19, 2003

    Report

    Report Number
    1423500-2003-00892
    Event Type
    Malfunction
    Date Received
    August 19, 2003
    Date of Event
    July 31, 2003
    Report Date
    July 31, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOME PT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR 2240 MESSAGE THAT APPEARED ON THE DISPLAY OF THE HP'S HOMECHOICE MACHINE DURING DWELL 2/4 OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. REPORTEDLY, WHILE HOSPITALIZED, A SUPPLY BAG FELL AND BECAME DISCONNECTED FROM THE SUPPLY LINE OF THE HOMECHOICE SET DUE TO IT HAVING BEEN STACKED ON TOP OF THE HEATER BAG DURING THERAPY. THE HP'S NURSE THEN WIPED THE SPIKE OF THE SUPPLY LINE AND THE ADMINISTRATION PORT OF THE SUPPLY BAG WITH IODINE SOLUTION AND GAUZE AND RECONNECTED THE SUPPLY LINE TO THE SUPPLY BAG. BAXTER'S TSC ASSISTED THE HP IN ENDING THERAPY EARLY. THERAPY WAS COMPLETED BY SETTING UP WITH NEW SUPPLIES. NO PT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER THE HP'S 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 CORP NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR CAPD TRANSFER SET, 2003.| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2003.| 15 LITER DRAINAGE BAG, 2003.| DIANEAL LOW CALCIUM SOLUTIN (STRENGTH UNK), 2003.