BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 556251 · Received May 3, 2004

    Report

    Report Number
    1423500-2004-00420
    Event Type
    Malfunction
    Date Received
    May 3, 2004
    Date of Event
    April 10, 2004
    Report Date
    April 10, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A HOME PT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER FOR ASSISTANCE REGARDING A "CHECK SUPPLY LINE" ALARM RECEIVED DURING THE LAST FILL OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. REPORTEDLY, THE HOME PT HAD DISCONNECTED THE HEART BAG FROM THE HEATER LINE OF THE HOMECHOICE SET, AND A SUPPLY BAG FROM A SUPPLY LINE OF THE HOMECHOICE SET. THE HOME PT THEN PROCEEDED TO RE-CONNECT THE HEATER BAG TO THE SUPPLY LINE, AND THE SUPPLY BAG TO THE HEATER 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 THE 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 CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR MINICAKP PD TRANSFER SET WITH TWIST CLAMP-EXTRA| HOMECHOICE AUTOMATER PD SYSTEN 115 VOLT, 2004| SHORT 2004| DINEAL PD2 SOLUTION (STRENGTH UNK), 2004