BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2923159 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01449
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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 ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A LOW ULTRAFILTRATION ALARM DURING DRAIN 5 OF 5 ON THE HOMECHOICE MACHINE (HC). THE HOME PATIENT(HP) STATED THEY HAVE A CURRENT DRAIN VOLUME OF 4500ML AND CYCLE ULTRAFILTRATION OF 1512ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO REVIEW PROGRAMMING. THE FILL VOLUME WAS 2300ML, LAST FILL VOLUME OF 0ML, AND TOTAL ULTRAFILTRATION OF 1700ML. THE HP STATED HE IS USING 2.5% BAGS. THE TSR EXPLAINED THE DISPLAY AND ASSISTED THE HP TO END THERAPY. THE HC UNIT WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27569 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

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