BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2931550 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02068
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 6, 2013
    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 HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. 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)..IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED DURING EVALUATION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY; THEREFORE THE DEVICE DID MEET PRODUCT SPECIFICATION RELATED TO THE REPORTED ISSUE OF IIPV-ADULT (HIGH DRAIN VOLUME 101). THE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR WITH INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES(BTS) REGARDING ASSISTANCE WITH A HI DRAIN 101 ALARM AT THE START OF THERAPY ON THE HOMECHOICE MACHINE(HC). THE TECHNICAL SERVICE REPRESENTATIVE(TSR) ASSISTED THE CAREGIVER(CG) TO REVIEW THERAPY. THE INITIAL DRAIN VOLUME WAS 649ML, RECOVERED DRAIN VOLUME OF 0ML, LAST FILL VOLUME OF 975ML, TOTAL FILL OF 5993ML, TOTAL DRAIN OF 7033ML, AVERAGE DWELL TIME OF 1:34, AVERAGE DRAIN TIME OF :36, TOTAL ULTRAFILTRATION(UF) OF 1039ML, CYCLE 4 UF OF -154ML, CYCLE 3 UF OF -175ML, CYCLE 2 UF OF -184, CYCLE 1 UF OF -1533ML, 0 BYPASSES, MANUAL DRAIN SET TO 0, AND CHANGES TO THERAPY. THE CG STATED THE HOME PATIENT(HP) DID A MANUAL BAG OF 1500ML WITH THE PERITONEAL DIALYSIS NURSE. THE CG STATED THE NURSE ONLY PARTIALLY DRAINED THE HP. THE CG STATED THE HP WILL PERFORM MANUAL EXCHANGES TONIGHT. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37080 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE- LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE