BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1920376 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06776
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS NOT IDENTIFIED. THE LOT INFORMATION WAS UNKNOWN, SO A BATCH REVIEW WAS NOT PERFORMED. THE HOMECHOICE PATIENT AT-HOMEGUIDE INSTRUCTS PATIENTS NOT TO REPLACE EMPTY SOLUTION BAGS OR RECONNECTED DISCONNECTED SOLUTION BAGS DURING THERAPY. IF A BAG BECOMES DISCONNECTED DURING THERAPY, PATIENTS ARE INSTRUCTED TO FOLLOW THE "END THERAPY EARLY PROCEDURE". THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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 THOUGHT (B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED BAXTER GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A CHECK SUPPLY LINE ALARM WHILE USING THE HOMECHOICE DURING FILL 4 OF 4. THE PATIENT EXPLAINED THEY REMOVED THE FINAL BAG AND THEN RECONNECTED IT. GTS ASSISTED THE PATIENT IN ENDING THERAPY, AND THE PATIENT ELECTED TO COMPLETE THERAPY WITH MANUAL SUPPLIES. THE PATIENT WAS ADVISED TO CONTACT THEIR DIALYSIS NURSE REGARDING SWITCHING THE SOLUTION BAG AND ANY POSSIBLE STERILITY ISSUES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1