BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3180677 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16037
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 FOR A SYSTEM ERROR 2240 WHERE THE PATIENT CONNECTED THE PATIENT LINE EXTENSION AFTER PRIMING. 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 INSTRUCTS THE USER TO CONNECT THE PATIENT LINE EXTENSION TO THE PATIENT LINE PRIOR TO PRIMING. IT INSTRUCTS THE USER TO MAKE SURE THE PATIENT LINE EXTENSION IS CORRECTLY POSITIONED IN THE ORGANIZER AND VERIFY THAT THE PATIENT LINE EXTENSION IS PLACED IN THE LEFT SLOT OF THE BLUE ORGANIZER. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, 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 DURING INITIAL DRAIN. THE HP DID NOT CONNECT THE PATIENT LINE EXTENSION UNTIL AFTER PRIMING. THE HP THEN CONNECTED TO THE PATIENT LINE TO BEGIN THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE PATIENT LINE EXTENSION NEEDS TO BE CONNECTED PRIOR TO PRIMING. THE TSR ASSISTED THE HP IN CLEARING THE ALARM AND ADVISED THE HP TO START OVER WITH 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
    279872 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE