BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2222624 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11224
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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). THIS COMPLAINT FOR A USE ERROR WAS CONFIRMED. AS PER THE COMPLAINT INFORMATION- THE CASSETTE WAS REPLACED WHILE THE SOLUTION BAGS WERE REUSED FOR THERAPY. THE CAUSE WAS UNDETERMINED. 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

    DURING TROUBLESHOOTING OF A CHECK FINAL LINE ALARM, A CARE GIVER(CG) REPORTED TO THE BAXTER TECHNICAL REPRESENTATIVE (TSR) THAT THE CG HAD CHANGED THE CASSETTE AND NOT THE BAGS. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE THAT ONCE A SETUP WAS COMPLETE SHE NEEDED TO CHANGE THE CASSETTE AND THE BAGS. THE CG STATED THAT THE HOSPITAL LETS HER CHANGE THE FINAL BAG. THE TSR REITERATED THE NEED TO SETUP WITH ALL NEW SUPPLIES. THE CG HAD THE TSR REMAIN ON THE LINE WHILE SHE SET UP WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. 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