BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2082104 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05640
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIMING. THE HOME PATIENT (HP) HAS THREE BAGS CONNECTED AND SOLUTION IN DRAIN BAG. THE HP RESTARTED PRIMING. THE HP NOW STATED THAT SHE CHANGED THE SET, BUT NOT THE BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO RESTART WITH NEW BAGS AND SET. THE HC DEVICE WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    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