BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 3240043 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19262
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS ORIGINALLY MANUFACTURED BEFORE THE YEAR 2000. A DEVICE HISTORY AND SERVICE HISTORY REVIEW WERE PERFORMED WITH NO ISSUES FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED A HOME PATIENT (HP) FELT OVERFILLED BY A HOMECHOICE CYCLER AND BECAME SHORT OF BREATH DURING PERITONEAL DIALYSIS (PD) THERAPY. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS NOT REMOVING EXTRA FLUID. THERE WERE NO FILL OR DRAIN VOLUMES REPORTED. THE NURSE WAS CONTACTED TO REVIEW PROGRAMMING OF THE DEVICE. THE PATIENT DISCONTINUED USE OF THE HOMECHOICE AND IS NOW PERFORMING BACK-UP MANUAL THERAPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339662 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL 1.5% & 2.5%