BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE PRO

    MDR report key: 4142462 · Received October 5, 2014

    Report

    Report Number
    1416980-2014-34561
    Event Type
    Injury
    Date Received
    October 5, 2014
    Report Date
    September 9, 2014
    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

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY REVIEW REVEALED NO NONCONFORMITIES, REWORK, OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT OF HERNIA. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). HE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A HERNIA THAT RUPTURED COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND UNDERWENT SURGERY TO REPAIR THE RUPTURE. THE HP WAS SWITCHED TO HEMODIALYSIS FOR UNKNOWN AMOUNT OF TIME AND AS OF THE DATE OF THIS REPORT, HAS RETURNED BACK TO PD THERAPY. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT HAD RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621975 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL