BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2943436 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02927
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION; THEREFORE, NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING AN ALARM DURING THE INITIAL DRAIN ON THE HOMECHOICE (HC) AND THE REGISTERED NURSE (RN) REPRIMED THE SAME SET. THE RN HAD LEFT THE ROOM AFTER PRIMING AND THE HOME PATIENT (HP) RECEIVED THE SE 2240 IN THE INITIAL DRAIN. THE RN WAS NOT THERE AT THE TIME OF THE ALARM AND COULD NOT PROVIDE ANY DETAILS. THE RN CAME BACK AND DISCONNECTED THE HP. THE RN THEN TOOK THE SET AND RE-PRIMED IT. THE HC PRIMED. THE RN WANTED TO KNOW IF THERE WAS A PROBLEM WITH THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED AND GAVE POSSIBLE CAUSES FOR THE ALARM. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47447 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE