BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 462246 · Received May 20, 2003

    Report

    Report Number
    1423500-2003-00504
    Event Type
    Malfunction
    Date Received
    May 20, 2003
    Date of Event
    May 2, 2003
    Report Date
    May 2, 2003
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN LPN CARING FOR A REHAB PATIENT CALLED THE BAXTER TECHNICAL SERVICE CENTER TO REPORT RECEIVING A CHECK LINES & BAGS ALARM DURING PRIME OF APD TREATMENT ON THE HOMECHOICE MACHINE. THE LPN REPORTEDLY OPENED THE HOMECHOICE MACHINE DOOR AND THEN RECEIVED A SYSTEM ERROR 2084 ALARM. A BAXTER OPERATIONAL SUPPORT REPRESENTATIVE (OSR) ASSISTED THE LPN IN TROUBLESHOOTING THE ALARM. AT THIS TIME, THE LPN INFORMED THE OSR THAT THE PATIENT WAS CONNECTED TO THE HOMECHOICE SET PATIENT LINE DURING PRIME. THE OSR THEN ADVISED THE LPN THAT THE PATIENT SHOULD NOT BE CONNECTED IN PRIME AND INSTRUCTED THE LPN TO DISCARD THE ENTIRE SET UP AND START OVER WITH NEW SUPPLIES. THE LPN REPORTED NO PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THE 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 12 FT. EXTENSION SET, 2003.| DIANEAL LOW CALCIUM SOLUTION (STRENGTH UNK), 2003,| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT, 2003,