BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1845016 · Received September 27, 2010

    Report

    Report Number
    1423500-2010-03745
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF THERAPY CHANGE DURING USE WAS NOT CONFIRMED IN THE DEVICE LOGS OR DUPLICATED DURING THE EVALUATION PERFORMED BY THE PAL (PRODUCT ANALYSIS LAB). THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THE PAL EVALUATED THE DEVICE. THE DEVICE FUNCTIONED PROPERLY DURING THE EVALUATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM. THE ASSIGNABLE CAUSE FOR THE THERAPY CHANGE DURING USE WAS UNDETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A THERAPY PROGRAM CHANGE WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DRAIN 1. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED FOR A SWAP OF THE DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. FOLLOW UP WITH THE NURSE REVEALED THAT THE PATIENT DID RECEIVE THE NEW HOMECHOICE DEVICE AND IS CONTINUING WITH THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY/FKX FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR