BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3190719 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16452
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT RECEIVED A SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) DURING THE INITIAL DRAIN OF PERITONEAL DIALYSIS (PD) THERAPY WHILE CONNECTED TO THE HC DEVICE WITH A 3-PRONG AUTOMATED PD SET WITH CASSETTE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO START OVER WITH NEW SUPPLIES AND TO CONTACT THE REGISTERED NURSE (RN) REGARDING THE ALARM. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291194 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE