BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3222219 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18068
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. THIS WAS A REPORT OF A SYSTEM ERROR 2240 WHERE CAREGIVER STARTED THERAPY BEFORE CONNECTING THE HOME PATIENT TO THE HOMECHOICE MACHINE. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR WHEN AND HOW TO CONNECT TO THE DISPOSABLE SET AND INSTRUCTS THE USER TO CONNECT THE TRANSFER SET TO THE PATIENT LINE PRIOR TO STARTING THE INITIAL DRAIN. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING PERITONEAL DIALYSIS, A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR 2240 (AIR IN SET) ALARM ON A HOMECHOICE (HC) MACHINE WITH THE HP CONNECTED IN INITIAL DRAIN. THE CAREGIVER (CG) STATED THAT THEY PRESSED GO BEFORE CONNECTING THE HP TO THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HP NEEDED TO BE CONNECTED FIRST AND THEN PRESS GO. THE TSR ADVISED THE CG TO START OVER USING NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322819 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE