BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2823141 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04331
    Event Type
    Malfunction
    Date Received
    November 7, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER IN REFERENCE TO THE USE ERROR; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    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, THE CUSTOMER SWITCHED A HEATER 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. A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT. THE HOME PATIENT (HP) STATED SHE CHANGED OUT THE HEATER BAG ONLY AND WAS STILL GETTING THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP THAT SHE HAS NOW COMPROMISED HER SETUP. THE TSR EXPLAINED IF SHE THINKS SOMETHING ON THE SETUP NEEDS TO BE REPLACED, THE ENTIRE SETUP NEEDS TO BE REPLACED, NOT JUST ONE PIECE. THE TSR ASSISTED THE HP WITH ENDING THERAPY. THE TSR ADVISED THE HP TO DISPOSE OF CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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