BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1038512 · Received May 6, 2008

    Report

    Report Number
    1423500-2008-00316
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKK
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED TO GO TO THE PROD ANALYSIS LAB FOR EVAL. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVAL OR IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE NURSE (RN) OF A HOME PT (HP) CONTACTED A TECHNICAL SVC REP (TSR) IN 2008 AND REPORTED THE HP WAS FLUID OVERLOADED USING THE HOMECHOICE SYS. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE PT WAS HOSPITALIZED. THE RN REQUESTED A SWAP AND THE TSR SUBSEQUENTLY SWAPPED THE HP'S DEVICE. FOLLOW UP WITH THE RN ON NINE DAYS LATER REVEALED THE HP WAS HOSPITALIZED FOR ONE WEEK DUE TO FLUID OVERLOAD AND WAS RELEASED FROM THE HOSP ON ORIGINAL DATE, AT WHICH TIME THE RN SWAPPED THE CYCLER. THE HP HAD PANCREATITIS WHILE HOSPITALIZED, WHICH THE RN FEELS MAY HAVE BEEN CAUSED BY THE HP BEING FLUID OVERLOADED. THE RN DOES NOT FEEL THAT ANY DEVICE FAILURE OR MALFUNCTION HAD OCCURRED. THE RN FELT THAT THE HP'S HOSPITALIZATION WAS CAUSED BY THE HP BEING UNDERDIALYZED AS A RESULT OF HER OWN USER ERROR. THE HP KEPT REPEATEDLY CHANGING THE PRESCRIPTION ON HER CYCLER, AND THE RN HAD TO MAKE 3 SEPARATE HOME VISITS TO CORRECT IT. THE RN RELATES THAT ON ONE OCCASION SHE FOUND THAT THE TOTAL VOLUME OF FLUID TO BE USED FOR THE AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY HAD BEEN CHANGED ON THE CYCLER BY THE HP FROM 12000MLS TO 2000MLS. THE RN RELATES THAT THE HP SEEMED TO HAVE LOST FAITH IN THE CYCLER, AND SHE SWAPPED IT OUT IN THE HOPES THAT THIS WOULD STOP THE HP FROM CHANGING THE CYCLER'S PROGRAMMING. THE RN INDICATES THAT THE HP WAS DIALYZED AT THE HOSP, USING THE HOSPITAL'S CYCLER AND SHE HAS NO SPECIFIC DETAILS REGARDING THE HP'S WEIGHT OR TREATMENT RECEIVED. THE RN RELATES THAT THE HP HAS BEEN USING THE REPLACEMENT CYCLER AND HAS ALREADY ATTEMPTED TO ALTER THE PROGRAMMING ON IT. THE RN HAS BEEN WORKING WITH THE HP'S SOCIAL WORKER TO TRY AND RESOLVE THESE ISSUES. CORPORATE PROD SURVEILLANCE INFORMED THE RN OF THE PROGRAM LOCKED FEATURE OF THE CYCLER, WHICH IS ACCESSIBLE TO THE RN ONLY FROM THE NURSE'S MENU. RN RELATES THAT AS A RESULT OF THIS AND THE CROSS-REFERENCE COMPLAINT INCIDENT, SHE WILL LOCK THE HP OUT OF THE PROGRAMMING IN ORDER TO PREVENT HER FROM MAKING CHANGES TO IT IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKK FKK BAXTER HEALTHCARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R