BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2874219 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07387
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WAS "GOING STRAIGHT TO FILL 1 WITHOUT DRAINING." THE CAUSE OF THE PROBLEM WAS THE INITIAL DRAIN ALARM WAS OFF, WHICH IS A USE ERROR. THE TSR ASSISTED THE PATIENT WITH CHANGING THE SETTING FOR THE INITIAL DRAIN ALARM AND CONTINUING TO MANUAL DRAIN. PER THE BAXTER HOMECHOICE OPERATOR'S MANUAL, USERS ARE ADVISED TO CHANGE THE SETTING FOR THE INITIAL DRAIN ALARM TO ON IF NEEDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) TO REPORT THE HOMECHOICE WOULD GO STRAIGHT TO FILL 1 WITHOUT DRAINING. THE REGISTERED NURSE (RN) WANTED TO CHECK THE INITIAL DRAIN ALARM (IDA). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE RN TO MAKE ADJUSTMENTS. THE INITIAL DRAIN ALARM (IDA) WAS SET TO OFF. THE RN CHANGED THE IDA SETTING AND THE TSR ASSISTED TO MANUAL DRAIN. THE HOME PATIENT (HP) RESUMED THERAPY. THE HOMECHOICE UNIT WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 CASSETTE