BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 368429 · Received December 19, 2001

    Report

    Report Number
    1423500-2001-01775
    Event Type
    Malfunction
    Date Received
    December 19, 2001
    Date of Event
    December 1, 2001
    Report Date
    December 1, 2001
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A "SYSTEM ERROR 2240" MESSAGE THAT HP RECEIVED ON THE DISPLAY OF HOME PATIENT'S HOMECHOICE MACHINE DURING DWELL 1 OF THEIR AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. REPORTEDLY, HP'S SPOUSE DISCONNECTED ONE OF THE SUPPLY BAGS FROM THE SUPPLY LINE OF THE HOMECHOICE SET DURING TREATMENT WITHOUT CLAMPING OFF THE SUPPLY LINE. HP THEN CONNECTED THE USED BAG TO A DIFFERENT LINE ON THE HOMECHOICE SET. "A FEW SECONDS LATER" HP RECEIVED A "SYSTEM ERROR 2240" ALARM. BAXTER'S QUALITY ASSURANCE DEPARTMENT ADVISED HP AGAINST RESPIKING USED BAGS AND MOVING BAGS FROM LINE TO LINE DURING APD THERAPY.RN WILL REVIEW PROPER PROCEDURES WITH HP. NO PT INJURY OR MEDICAL INTERVENTION WAS ASSOCITATED WITH THIS INCIDENT PER HP AND RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57460 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN