BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2832556 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05190
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 28, 2012
    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). THIS COMPLAINT FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT WAS CONFIRMED BECAUSE IT WAS REPORTED, DURING TROUBLE SHOOTING OF AN ALARM SITUATION, THAT THE CUSTOMER SWITCHED A SUPPLY BAG ONLY AND CONTINUED THERAPY WITH REST OF THE DISPOSABLE SINGLE USE SUPPLIES. THE CAUSE WAS UNDETERMINED. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE PREVENTION OF THE USE/USER ERROR RELATED TO THIS INCIDENT.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES THE ISSUE OF USE ERROR-REUSE OF SUPPLIES. THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING FILL. THE HP DISCONNECTED A BAG AND CONNECTED A FULL BAG (CONTINUING THERAPY WITH THE REST OF THE DISPOSABLE SINGLE USE SUPPLIES) BUT THEN ENDED THERAPY. 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
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE