BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2031629 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03733
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE COMPLAINT INFORMATION, THE CAUSE IS USER ERROR / MIS-USE. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IDENTIFIED IN THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    DURING A CUSTOMER CONTACT TO BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING FILL, THE HOME PATIENT (HP) STATED THAT ONLY THE FINAL BAG HAD SOLUTION, HOWEVER, HE HAD DISCONNECTED FROM THE HC AND NEVER PLACED A FLEXI CAP ON THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER ON THE HC TO END OF THERAPY. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S NURSE ON (B)(6) 2011 TO NOTIFY HER OF THE PATIENT'S USE ERROR. THE NURSE STATED THAT THE PATIENT HAS RESUMED THERAPY WITH NO FURTHER ISSUES. THE PATIENT HAS NOT HAD ANY INFECTION OR PATIENT INJURY OR MEDICAL INTERVENTION DUE TO THIS EVENT. THE PATIENT HAS BEEN TO THE CLINIC SINCE THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE