BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3061194 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09402
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) AND A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CONNECTION ISSUE WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE; THE HOME PATIENT (HP) WAS NOT CONNECTED. THE HP STATED THAT AFTER PRIME BUT BEFORE THE INITIAL DRAIN, ONE OF THE SUPPLY LINES BECAME DISCONNECTED FROM A SUPPLY BAG. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT 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
    162611 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE