BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 3203173 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17090
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY AND SERVICE HISTORY WAS PERFORMED WHICH DID NOT INDICATE ANY ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF PATIENT SYMPTOM - OVERFILL. NO IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENTS OR RELATED DEVICE ISSUES WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT THAT EXPERIENCED A HERNIA DUE TO AN OVERFILL EVENT THAT OCCURRED WHILE HOSPITALIZED FOR AN UNRELATED ISSUE. PER THE NURSE "THE PATIENT FELT VERY FULL WHILE USING THE CYCLER, SO THE NURSE DRAINED HIM. THE NURSE DRAINED 4 L OUT." THE HOME PATIENT WAS TAKEN OFF OF PERITONEAL DIALYSIS THERAPY AND STARTED ON HEMODIALYSIS. THE HOME PATIENT IS CURRENTLY RECOVERING FROM THE HERNIA. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302562 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTRANEAL| DIANEAL| COUMADIN