BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2770273 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01438
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE DUE TO USE ERROR, BECAUSE THE PATIENT LEFT A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOME CHOICE (HC) DISPLAY WHILE THE HOME PATIENT (HP) WAS CONNECTED. THE NURSE STATED THAT HOME PATIENT (HP) LEFT A LINE OPEN. 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
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE