BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 452153 · Received March 31, 2003

    Report

    Report Number
    1423500-2003-00336
    Event Type
    Malfunction
    Date Received
    March 31, 2003
    Date of Event
    March 7, 2003
    Report Date
    March 7, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A HOME PT'S FAMILY MEMBER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 MESSAGE THAT APPEARED ON THE DISPLAY OF THE HOME PT'S HOMECHOICE MACHINE DURING DWELL 1/10 OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. PER INITIAL REPORT, THE CUSTOMER HAD ERRONEOUSLY CONNECTED A SUPPLY BAG TO THE FINAL LINE OF THE HOMECHOICE SET. AFTER NOTING THIS THE CUSTOMER DISCONNECTED THE SUPPLY BAG FROM THE FINAL LINE AND RECONNECTED THE SUPPLY BAG TO THE APPROPRIATE SUPPLY LINE. BAXTER'S TECHNICAL SERVICE CENTER ASSISTED THE HOME PT IN ENDING THERAPY EARLY. NO PT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER FAMILY MEMBER OF HOME PT.

    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 CORP NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN HOMECHOICE PRO AUTOMATED PD SYSTEM 115 VOLT, 2003| CAPD TRANSFER SET, 2003| DIANEAL PD2 SOLUTION (STRENGTH UNK), 2003