BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2182934 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09911
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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 CHECK SUPPLY LINE ALARM WAS NOT CONFIRMED. THE ROOT CAUSE IS THAT THE PATIENT DISCONNECTED SOLUTION BAGS DURING THERAPY. A LABELING REVIEW FOUND THE HOME CHOICE USER MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE IS UNKNOWN, THEREFOR THE 510K NUMBER IS UNKNOWN. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOME CHOICE (HC) DURING LAST DWELL, THE CARE GIVER (CG) STATED THE LAST SUPPLY BAG WOULD NOT TRANSFER TO THE HEATER BAG SO THE CG DISCONNECTED THE HEATER BAG AND ADDED A NEW SUPPLY BAG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG WITH ENDING THERAPY AND REFERRED THEM TO THE NURSE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 HOME CHOICE