BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3031595 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08173
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LABELING REVIEW FOUND THAT ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY." IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING AN ALARM ON THEIR HOMECHOICE, AND THE PATIENT HAD STARTED THERAPY OVER REUSING THE SAME SUPPLIES. THE PATIENT WAS CONNECTED. THE TSR REFERRED THE HP TO THEIR REGISTERED NURSE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134692 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE