BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2983574 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04968
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS THE SAME PATIENT AS (B)(4). THE REPORTED ISSUE WAS NOT CONFIRMED AND THE CAUSE WAS UNDETERMINED BECAUSE THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED FOR THIS USE ERROR - FAILED TO FOLLOW THERAPY STEPS COMPLAINT, BECAUSE THERE WAS A DEFINED USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. THE CAUSE IS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SUPPOSED TO USE A HOMECHOICE AUTOMATED PD SET WITH 3-PRONG CASSETTE, BUT INSTEAD USED A HOMECHOICE AUTOMATED PD SET WITH 4-PRONG CASSETTE TO PERFORM PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT CUT THE TUBING ON THE CASSETTE AND TAPED THE TUBING TOGETHER AND CONTINUED TO USE THIS CASSETTE FOR PD THERAPY. THE HOME CARE SERVICE REPRESENTATIVE (HCSR) INSTRUCTED THE PATIENT TO DISCONTINUE USE OF THE INCORRECT/CUT CASSETTE AND NOTIFIED THE PD NURSE OF THE ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88238 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1