BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3063515 · Received April 17, 2013

    Report

    Report Number
    1416980-2013-09537
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE REPORTED ISSUE WAS NOT CONFIRMED AND THE CAUSE WAS NOT DETERMINED. REVIEW OF 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. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A HIGH DRAIN 105/CALL PD NURSE ALARM ON A HOMECHOICE (HC) DEVICE AT THE END OF THERAPY. HIGH DRAIN 105/CALL PD NURSE ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE BAXTER TECHNICAL SUPPORT REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE HOME PATIENT (HP) STATED, HE NORMALLY USED TWO GREEN BAGS BUT HAD USED ONE RED BAG IN PLACE OF ONE GREEN BAG FOR THIS THERAPY. THE HP DID NOT KNOW HOW MUCH THE ULTRAFILTRATION (UF) NORMALLY WAS, BUT TODAY'S UF THROUGH THE LAST CYCLE COMPLETED WAS 1636ML. THE HP SAID SHE SLEEPS CURLED UP AND FLUID IS NOT ABLE TO DRAIN FULLY DUE TO HER POSITIONING. THE HP SAID, HER DRY WEIGHT IS (B)(6), THE DRAIN VOLUME WAS 4001 AND THE FILL VOLUME WAS 1800. (4001-1800)/1800 = 1.22 WHICH IS GREATER THAN 0.6 AND MEETS CRITERIA FOR INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE HP DID NOT WANT A SWAP. SHE SAID, SHE WOULD CALL HER NURSE TO INFORM HER OF THE ALARM. THE HOMECHOICE MEETS DEVICE SPECIFICATIONS AND IS SAFE TO LEAVE IN THE CUSTOMER?S HOME. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166348 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE