BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 3832554 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17003
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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 IN THE LUNGS. ON AN UNREPORTED DATE, THE PT CONTACTED BAXTER DUE TO EXPERIENCING SHORTNESS OF BREATH DURING A FILL. THE PT PERFORMED A MANUAL DRAIN (DRAIN VOLUME UNKNOWN). THE MANUAL DRAIN DID NOT RELIEVE THE SYMPTOMS SO THE PT WENT TO THE EMERGENCY ROOM. THE PT WAS GIVEN OXYGEN AND ADMITTED TO THE HOSPITAL FOR 3-4 DAYS. THE PT REPORTED THAT HE HAD FLUID IN THE LUNGS. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311246 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R