BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 3853044 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18085
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S FLUID OVERFILL HAD A MANIFESTATION OF TROUBLE BREATHING. THE DEVICE WAS NOT RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) EXPERIENCED FLUID OVERLOAD, CHEST PAIN, PLEURAL EFFUSION AND OTHER EVENTS. THREE DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PT WAS HOSPITALIZED FOR THE EVENTS. ON AN UNKNOWN DATE DURING HOSPITALIZATION, PD THERAPY WAS STOPPED DUE TO OVERFILL. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH ANTIBIOTICS AND DAILY HEMODIALYSIS FOR THE EVENTS OF FLUID OVERLOAD AND PLEURAL EFFUSION. THE PT RECOVERED FROM THE EVENTS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332974 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R DIANEAL 2.5% PD4 AND DIANEAL 4.25%PD4