BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2945670 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03032
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 16, 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 REPORTED ISSUE WAS CONFIRMED BASED ON THE VOLUMES PROVIDED BY THE CUSTOMER. 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. THE ASSIGNABLE CAUSE OF THE INCREASE INTRAPERITONEAL VOLUME EVENT WAS UNDETERMINED.

    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 RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING ASSISTANCE WITH A HIGH ULTRAFILTRATION ON THE HOMECHOICE MACHINE (HC). THE HOME PATIENT (HP) STATED HE HAS A TOTAL ULTRAFILTRATION OF 2616ML. THE HP STATED HE HAD A DRAIN OF 4900ML A FEW DAYS AGO IN DRAIN 3 OF 5. THE HP STATED HE HAS AN ULTRAFILTRATION OF 1600-2600ML REGULARLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CONTACT HIS NURSE TO TALK ABOUT THE MINIMUM DRAIN PERCENTAGE. THE HP STATED HE USES 2.25% FOR 2 DAYS AND THEN SWITCHES TO 4.25% WHEN HE HAS SWELLING OR HAS ABSORBED FLUID. THE HP STATED HIS ANKLES WERE SWOLLEN LAST NIGHT AND HE USED THE 4.25% SOLUTION. THE HP HAD A CYCLE 5 ULTRAFILTRATION (UF) OF 267ML, CYCLE 4 UF OF 777ML, CYCLE 3 UF OF 372ML, CYCLE 2 UF OF 595ML, AND CYCLE 1 UF OF 605ML. 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
    51103 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE