BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2973806 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04431
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF HIGH DRAIN 101 (IIPV-ADULT). THE DEVICE IS NO LONGER IN ITS ORIGINAL MANUFACTURE CONDITION AND ADDITIONAL MANUFACTURE RECORD REVIEW IS NOT REQUIRED. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HIGH DRAIN 101 ON THE HOMECHOICE (HC) MACHINE DURING USE, PATIENT CONNECTED IN DRAIN 1. THE DRAIN VOLUME WAS 5998ML. THE HOME PATIENT (HP) HAS A 0ML IN INITIAL DRAIN ALARM AND HAD A 2500ML IN THE LAST FILL. THE HP HAD DRAINED 17ML BEFORE THE HC CYCLED TO FILL 1. THE HP CALLED THE REGISTERED NURSE (RN) WHO THEN CALLED BAXTER. THE RN REALIZED THAT THIS WAS A PROGRAM ISSUE AND NOT A HC PROBLEM. THE RN DID NOT WANT THE HC SWAPPED AND WOULD CALL THE HP BACK TO ADJUST THE INITIAL DRAIN ALARM SETTING. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78196 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR