BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1880134 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04783
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE PREVIOUS SERVICE RECORD, (B)(4) 2010, SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE TAMPA BAY FACILITY. NO ISSUE WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE DIFFICULTY OF USE ERROR. THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR ANY ISSUE RELATED TO USE ERROR. THE ROOT CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR SINCE THE RESULTS WERE NOT EXPECTED BY THE USER. THE CURRENT LABELING FOR THE HOMECHOICE/HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, DOCUMENT NUMBER (B)(4) ((B)(4), 2009 RELEASE) WAS FOUND TO BE SUFFICIENT. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOMECHOICE (HC) WAS DISPLAYING 65 CYCLES INSTEAD OF 4, WHICH OCCURRED DURING FILL. THE CAREGIVER STATED SHE USUALLY SETS UP THE HC FOR THE HOME PATIENT (HP), BUT TONIGHT THE HP SETUP HER OWN HC. THE CG STATED THE HP WAS HAVING PROBLEMS SETTING UP THE HC AND THE CG DID NOT KNOW WHAT BUTTONS THE HP PRESSED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE PROGRAMMING REVIEWED AND ADVISED THE CG TO END THE THERAPY AND CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) FOR FURTHER INSTRUCTIONS AND REVIEW OF THE PROGRAMMING. FOLLOW UP WITH THE NURSE REVEALED THAT THE CAREGIVER CALLED HER IMMEDIATELY AND THE PROGRAM CHANGE WAS DUE TO USER ERROR. THE NURSE ADDRESSED THE SITUATION AND CHANGED THE PROGRAM TO THE PRESCRIBED SETTINGS. THERE WAS NOT MEDICAL INTERVENTION OR PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR