BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122316 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07540
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THERE WAS NO ALLEGATION AGAINST ANY BAXTER PRODUCTS, NO DEVICE EVALUATION OR BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A USER ERROR - FAILED TO FOLLOW THERAPY STEPS WAS NOT CONFIRMED. THE ROOT CAUSE IS THAT THE PATIENT REUSED SOLUTION BAGS. A LABELING REVIEW FOUND THE HOME CHOICE USER MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR AN UNRELATED ALARM, THE HOME PATIENT (HP) STATED SHE JUST REPLACED THE CASSETTE. THE HP CONFIRMED THERAPY HAS CONTINUED WITHOUT INCIDENT. PRODUCT SURVEILLANCE REFERRED THE HP TO THE USER MANUAL AND ADVISED THAT REPLACING THE ENTIRE SETUP IS RECOMMENDED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 66 YR