BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3820002 · Received May 20, 2014

    Report

    Report Number
    1416980-2014-16211
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF AN UNRELATED ALARM, IT WAS REPORTED THAT SOLUTION WAS LEAKING OUT OF THE PATIENT LINE. THE EVENT OCCURRED DURING DRAIN ONE OF FOUR ON THE HOME CHOICE (HC) AND THE HOME PATIENT (HP) WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. DURING FOLLOW UP WITH THE HP, THERE WAS NOTHING UNUSUAL NOTED WITH THE SUPPLIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE LEAK. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299607 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR HOMECHOICE