BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2931806 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02081
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR (SE) 2240 WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR, DUE TO AN OPEN CLAMP. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) AND SE 2367 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DISPLAY WHILE THE HOME PATIENT (HP) WAS CONNECTED, IN DWELL 3 OF 5. THE HOME PATIENT (HP) STATED THAT THERE ARE TWO UNUSED LINES IN THE ORGANIZER AND BOTH CLAMPS ARE OPENED. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) INFORMED THE HP THAT THE CLAMPS SHOULD BE CLOSED IF NOT BEING USED. THE HP STATED THEY WILL NOT RESTART THERAPY TONIGHT. THE TSR ASSISTED THE HP TO END THERAPY. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37275 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE