BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2945556 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03027
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    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 CONDITION OF HIGH DRAIN 102 ALARM WAS CONFIRMED. REVIEW OF SERVICE DATA REVEALED THERE IS NO PREVIOUS SERVICE HISTORY FOR THIS DEVICE. THE CAREGIVER INDICATED THE CAUSE WAS THE PATIENT PERFORMED A MANUAL OFF CYCLER FILL.

    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 HIGH DRAIN 102 ALARM DURING A PREVIOUS THERAPY ON THE HOMECHOICE MACHINE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE CAREGIVER (CG). THE CG STATED THE HOME PATIENT (HP) WAS GETTING LOW DRAIN VOLUME ALARMS, SO HE DISCONNECTED THE HP. THE CG STATED THE HP FILLED WITH 2000ML AND RECONNECTED TO THE HC. THE TSR REVIEWED THE PROGRAMMING. THERAPY WAS CONTINUOUS CYCLE PERITONEAL DIALYSIS WITH A TOTAL VOLUME OF 11000ML, FILL VOLUME OF 2200ML, LAST FILL VOLUME OF 2000ML, AND 4 CYCLES. THE THERAPY LOG SHOWED THE INITIAL DRAIN VOLUME WAS 1653ML, LAST FILL VOLUME OF 1911ML, TOTAL FILL OF TOTAL FILL VOLUME OF 8894ML, TOTAL DRAIN OF 14446, TOTAL ULTRAFILTRATION(UF) OF 5561ML, CYCLE 4 UF OF 143ML, CYCLE 3 UF OF 662ML, CYCLE 2 UF OF 3049ML, AND CYCLE 1 UF OF 1707ML. THE TSR EXPLAINED TO THE CG ABOUT NOT DISCONNECTING THE HP DURING THERAPY TO PERFORM A MANUAL FILL. THE CG STATED THE NURSE IS ALREADY AWARE. THE TSR EXPLAINED THE CAUSES FOR THE LOW DRAIN VOLUME ALARM. THE HP IS DRAINING TO THE TOILET WITH THE LINE SUBMERGED. THE TSR ADVISED THE CG TO CALL IF THEY GET A LOW DRAIN VOLUME ALARM FOR TROUBLESHOOTING ASSISTANCE. 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
    50926 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE