BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1936202 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07155
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A CHECK LINES AND BAGS ALARM. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. PER THE REPORT, THE BAGS WERE EMPTY. THE NURSE CUT THE SUPPLY BAGS OFF AND THERAPY WAS ENDED. IN A FOLLOW UP CALL BY PRODUCT SURVEILLANCE, THE NURSE STATED THAT THE PATIENT WAS PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. FROM THE DATA WITHIN THE REPORT, THE ROOT CAUSE WAS EMPTY SOLUTION BAGS. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE REPORTED USER ERROR IN THE 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 THROUGH (B)(4).

    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 A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOME CHOICE (HC) DURING FILL. THE REGISTERED NURSE (RN) STATED THAT THE SUPPLY BAGS WERE EMPTY AND CUT THE SUPPLY BAGS OFF. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED TO END THERAPY. A FOLLOW UP WITH THE RN WAS DONE BY PHONE; THE RN STATED THAT THE HOME PATIENT DID NOT DEVELOP ANY ADVERSE EVENT OR REQUIRE ANY MEDICAL INTERVENTION. THE RN STATED THE HP WAS PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THE RN STATED THAT THE EVENT OCCURRED AT THE NURSING HOME AND THEY WERE MADE AWARE OF THE EVENT RIGHT AWAY.

    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 77 YR PD CYCLER