BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 8-PRONG

    MDR report key: 350538 · Received August 28, 2001

    Report

    Report Number
    1423500-2001-01296
    Event Type
    Malfunction
    Date Received
    August 28, 2001
    Date of Event
    August 1, 2001
    Report Date
    August 1, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME PT'S FAMILY MEMBER CALLED THE BAXTER TECHNICAL SERVICE LINE DUE TO THE TUBING OF THE HOMECHOICE SET GETTING TWISTED WHILE THE PT WAS SLEEPING. FAMILY MEMBER NOTED THEY DISCONNECTED THE HOMECHOICE TUBING FROM THE TRANSFER SET TO UNTWIST AND RECONNECTED TO FINISH TREATMENT. RN NOTED THAT RN HAS REVIEWED PROPER PROCEDURE WITH THE FAMILY MEMBER AND PROVIDED SOME SUGGESTIONS TO THE FAMILY MEMBER TO KEEP THE TUBING IN PLACE WHILE THE PT SLEEPS. PER RN, NO PT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39260 HOMECHOICE AUTOMATED PD SET W/CASSETTE 8-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP NA H00L11060

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR