BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOME CHOICEPRO

    MDR report key: 4093807 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31591
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE PATIENT PASSING AWAY. AS THE DEVICE WAS NOT RETURNED A DEVICE ANALYSIS CANNOT BE COMPLETED; THEREFORE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) EXPERIENCED SHORTNESS OF BREATH, FLUID AROUND LUNGS AND COLLAPSED LUNG. THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. THE NURSE STATED THAT THE PATIENT WAS EXPERIENCING "DIFFICULTLY AND SHORTNESS OF BREATH FOR A COUPLE WEEKS BEFORE". ON AN UNKNOWN DATE, THE PATIENT HAD FLUID DRAINED OFF HIS LUNGS WHILE HOSPITALIZED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENTS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572861 HOME CHOICEPRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R DIANEAL 1,5%, 2.5% AND 4.25% AMBUFLEX