BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4173545 · Received October 15, 2014

    Report

    Report Number
    1416980-2014-35934
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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

    IT WAS REPORTED THAT THE SUPPLY LINE OF A CASSETTE DISCONNECTED FROM A SOLUTION BAG WHILE PERFORMING THERAPY ON THE HOMECHOICE DEVICE. THE PATIENT WAS CONNECTED TO THE HOMECHOICE AT THE TIME OF THE EVENT. THE DISCONNECTION OCCURRED WHILE THE PATIENT WAS SLEEPING. DURING FOLLOW UP, THERE WAS NOTHING UNUSUAL NOTED DURING SETUP THAT WOULD HAVE LEAD TO THE DISCONNECTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653643 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR HOMECHOICE