BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 3840794 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17410
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT LINKED TO THE REPORTED EVENT UNTIL AFTER THE DEVICE HAD BEEN SERVICED, A COMPLETE DEVICE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, A REVIEW OF THE DEVICE LOGS REVEALED NO FAILURE OR MALFUNCTION WITH THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE SERVICE HISTORY REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS DETERMINED TO MEET ELECTRICAL AND FUNCTIONAL PERFORMANCE SPECIFICATION REQUIREMENTS PER THE HOMECHOICE RITE (RETURN INSTRUMENT TEST/EVALUATION) TESTING. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR FLUID IN THE LUNGS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). IT WAS REPORTED THE PATIENT UNDERWENT A THORACENTESIS. THE PATIENT REPORTED THAT THE SURGEON BELIEVES THAT THE BUILDUP OF FLUID IN THE LUNGS WAS ASSOCIATED WITH PD THERAPY. IT WAS NOT REPORTED IF THERE WERE ANY OVERFILL EVENTS THAT OCCURRED PRIOR TO THIS HOSPITALIZATION. ON AN UNREPORTED DATE AFTER THE ¿SURGERY¿, THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS THERAPY. AT THE TIME OF THIS REPORT, THE OUTCOME OF FLUID IN THE LUNGS WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED BUT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318453 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention