BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2855041 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06344
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 10, 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). ADDITIONAL INFORMATION: THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE ROOT CAUSE WAS DETERMINED TO BE ONE OR MORE CYCLE ADVANCES TO THE NEXT FILL WHEN A SLOW / NO FLOW OCCURRED, ABOVE THE MIN DRAIN VOLUME THRESHOLD. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. THE REPORTED DIFFICULTY OF IIPV-ADULT (HIGH DRAIN VOLUME 103) WAS CONFIRMED IN THE CUSTOMER RETURNED DEVICE LOGS BUT NOT DUPLICATED DURING PAL EVALUATION. DEVICE PASSED HOMECHOICE RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL TESTING (TM# (B)(4)) AND HOMECHOICE RITE ELECTRICAL SAFETY ANALYZER TESTING (TM# (B)(4)). CRT (CYCLER REMOTE TOOLBOX) INDICATED ALL PRESSURES WERE CORRECT AND STABLE. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE MEETS SPECIFICATION FOR THE REPORTED ISSUE OF IIPV-ADULT (HIGH DRAIN VOLUME 103). 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 ALARM AT THE END OF THERAPY ON THE HOMECHOICE MACHINE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP). THE TSR ASSISTED THE HP TO REVIEW THE THERAPY LOG. THE HC DISPLAYED THE INITIAL DRAIN VOLUME OF 11 ML, LAST FILL VOLUME OF 14 ML, TOTAL FILL VOLUME OF 6870 ML, TOTAL DRAIN VOLUME OF 8702 ML, AVERAGE DWELL OF 1:07, AVERAGE DRAIN OF :41, TOTAL ULTRAFILTRATION (UF) OF 1831 ML, CYCLE 4 UF OF 232 ML, CYCLE 3 UF OF 2021 ML, CYCLE 2 UF OF -225 ML, CYCLE 1 UF OF -197 ML, 0 BYPASSES, AND 0 MANUAL DRAINS. HIGH DRAIN 103/CALL PD NURSE ALARM (INDICATES THE PATIENT DRAINED GREATER THAN (B)(4) OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA). THE NURSE WAS CONTACTED ON (B)(4) 2012. THE NURSE STATED THAT THE HOME PATIENT (HP) DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE NURSE STATED THE HP DID NOT REPORT ANY FURTHER ISSUES AND THEY WERE PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THERE WAS PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE