BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2964462 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03999
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS CONFIRMED OVER THE PHONE. REVIEW OF SERVICE HISTORY REVEALED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE CURRENT DIFFICULTY AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT. THE ASSIGNABLE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH DRAIN ALARM OCCURRED DURING DRAIN 1 OF 4 ON THE HOMECHOICE MACHINE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP). THE TSR ADVISED THE HP TO CONTACT THE NURSE REGARDING THE INITIAL DRAIN ALARM AT 700ML AND THE HP DOING A MANUAL FILL OF 2000ML PRIOR TO GETTING ON THE HC. THE CYCLE 4 ULTRAFILTRATION WAS 2732ML. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67200 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE