BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2230408 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11517
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOR A SYSTEM ERROR 2367 ALARM DURING DWELL WAS CONFIRMED BASED ON INFORMATION PROVIDED BY THE HOME PATIENT (HP) STATING THAT HE LEFT ONE CLAMP OPEN WHEN HE DISCONNECTED. THE CAUSE WAS DETERMINED TO BE USE ERROR DUE TO AN OPEN CLAMP. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR USE/USER ERROR RELATED TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. THE SAMPLE IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2367 WHICH OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING DWELL. THE HOME PATIENT (HP) STATED THAT HE HAD LEFT ONE CLAMP OPEN WHEN HE DISCONNECTED. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HAD THE HP DISCARD SUPPLIES. 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