BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2921420 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01344
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF INCREASED INTRAPERITONEAL VOLUME (IIPV) WAS CONFIRMED. REVIEW OF THE 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. THE ASSIGNABLE CAUSE OF THE IIPV EVENT WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, WITH THE INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A HIGH DRAIN 101 ALARM DURING A PREVIOUS THERAPY ON THE HOMECHOICE MACHINE(HC). THE CAREGIVER(CG) STATED THE HOME PATIENT(HP) HAD PERFORMED A MANUAL EXCHANGE DURING THEIR PRIOR THERAPY WITH A FILL VOLUME OF 2000ML. THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE CG TO REVIEW THE THERAPY LOG. THE INITIAL DRAIN VOLUME WAS SET TO 0ML. THE TSR REVIEWED THE PROGRAMMING TO FIND THE HC WAS SET FOR CONTINUOUS CYCLE PERITONEAL DIALYSIS WITH A TOTAL VOLUME OF 9000ML, FILL VOLUME OF 2000ML, LAST FILL VOLUME OF 1000ML, DEXTROSE SET TO SAME, AND 4 CYCLES. THE TSR REVIEWED THE THERAPY LOG. THE TOTAL VOLUME WAS 7997ML, TOTAL DRAIN OF 11787ML, TOTAL ULTRAFILTRATION(UF) OF 3798ML, AND CYCLE 1 UF OF 2266ML. THE TSR ATTEMPTED TO CONFERENCE THE NURSE IN, BUT THERE WAS NO ANSWER. THE TSR ADVISED THE CG TO FOLLOW UP WITH THE NURSE REGARDING ADJUSTING THE INITIAL DRAIN ALARM. 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
    27929 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE