BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 7535874 · Received May 22, 2018

    Report

    Report Number
    1416980-2018-03091
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 27, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. THE EVENT HISTORY LOG SHOWED THE PROGRAMMED I-DRAIN ALARM REMAINED AT 0 ML AFTER THE OFF-CYCLER EXCHANGE WAS PERFORMED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. ALL CONNECTIONS APPEAR CORRECT AND SECURE. THE CYCLER REMOTE TOOLBOX SOFTWARE WAS USED TO DIAGNOSE THE DEVICE¿S PNEUMATIC SYSTEM. NO LEAKS WERE DETECTED; ALL PRESSURES WERE CORRECT AND STABLE. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS. THE REPORTED CONDITION WAS NOT VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO A USE ERROR OF AN INAPPROPRIATELY PROGRAMMED INITIAL DRAIN ALARM SETTING. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO NOT CHANGE THE SETTINGS FOR THE THERAPY UNLESS DIRECTED BY THE NEPHROLOGIST OR NURSE. ALSO, IT WARNS THE USER THAT INCORRECT SETTINGS CAN LEAD TO SERIOUS INJURY OR DEATH. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED DIFFICULTY BREATHING AND ABDOMINAL FULLNESS WHILE PERFORMING AUTOMATED PD THERAPY WITH A HOMECHOICE (HC) DEVICE. THE ISSUE OCCURRED WHILE THE PATIENT WAS CONNECTED TO THE HC. THE NURSE ADVISED THAT THE HOME PATIENT HAD A MANUAL DRAIN VOLUME (DV) OF 1715 ML, A MANUAL FILL VOLUME (FV) OF 2000 ML, AN INITIAL DRAIN AMOUNT (IDA) OF 0 ML. THE PATIENT HAD A MIDDAY MANUAL EXCHANGE WHICH CONSISTED OF A MANUAL DRAIN OF THE LAST FILL VOLUME OF 1000ML THEN A MANUAL FILL VOLUME OF 2000ML. THE NURSE STATED, THE PATIENT ONLY DRAINED 11 ML IN THE INITIAL-DRAIN (I-DRAIN) AND THE MACHINE WENT ONTO FILL 1 BY ITSELF. THE NURSE STOPPED THE FILL WHEN THE PATIENT STATED THAT THEY WERE TOO FULL AND COULD NOT BREATHE WELL. A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) GUIDED THE NURSE TO SELECT A MANUAL DRAIN OF 2000 ML AND ONCE DRAINED, THE PATIENT FELT FINE. THE TSR EXPLAINED TO THE NURSE THAT THE IDA SETTING WAS SET TOO LOW. THE NURSE CHANGED THE IDA TO THE CORRECT IDA VOLUME OF 1400 ML. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE FOLLOWING DAY, THE PATIENT CONNECTED TO THE HC DEVICE FOR APD AND THERE WAS NO PROBLEM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375906 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other