BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 366446 · Received December 12, 2001

    Report

    Report Number
    1423500-2001-01738
    Event Type
    Malfunction
    Date Received
    December 12, 2001
    Date of Event
    November 14, 2001
    Report Date
    November 14, 2001
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A "CHECK LINES AND BAGS" MESSAGE THAT APPEARED ON THE DISPLAY OF THEIR HOMECHOICE MACHINE DURING THEIR AUTOMATED PERITONEAL DIALYSIS (APD) TREATMENT. REPORTEDLY, HP NOTED NO KINKS OR BENDS IN THE TUBING AND ALL CLAMPS WERE OPEN. IN AN ENDEAVOR TO FIX THE ISSUE, THE HP UNSPIKED ONE OF THEIR SUPPLY BAGS FROM THE SUPPLY LINE OF THE HOMECHOICE SET AND CONNECTED THE USED SUPPLY LINE TO A NEW SUPPLY BAG. WHEN THE HOMECHOICE MACHINE DIDN'T STOP ALARMING, THE HP CONTACTED THE TSC. THE TSC ASSISTED THE HP IN CLAMPING OFF THE REUSED SUPPLY LINE OF THE HOMECHOICE SET AND CONNECTING A NEW SUPPLY BAG TO AN UNUSED SUPPLY LINE OF THE HOMECHOICE SET, SO THE HP COULD COMPLETE THEIR THERAPY. PER HP'S FAMILY MEMBER AND HP'S RN, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56010 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN