BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1061041 · Received June 12, 2008

    Report

    Report Number
    1423500-2008-00491
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    December 19, 2007
    Report Date
    May 22, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADDITIONAL 510(K) NUMBER: K923065. H3: CUSTOMER SAMPLE RECEIVED; HOWEVER, EVALUATION NOT YET COMPLETED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) REPORTED THAT THERE IS "SOMETHING NOT RIGHT" USING THE HOMECHOICE CYCLER FOR AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE HP REPORTED THE CYCLER WAS PROGRAMMED FOR A FILL VOLUME OF 2500MLS AND A LAST FILL OF 2000MLS. THE HP REPORTED HE MANUALLY DRAINED 3000MLS OF FLUID ON (B) (6) 2008, WHICH WAS 1000MLS MORE THAN THE HP'S LAST FILL VOLUME OF 2000MLS. FOLLOW UP WITH THE HP'S DIALYSIS CENTER NURSE (RN) REVEALED SHE DOES NOT FEEL THAT ANY CYCLER FAILURE OR MALFUNCTION HAD OCCURRED. ACCORDING TO THE RN, THE HP HAS DEMENTIA AND DOES NOT FOLLOW HIS PERITONEAL DIALYSIS CENTER PRESCRIPTION, RESULTING IN UNDERDIALYZING. THE RN DENIED THAT THE HP WAS OVERFILLED AND STATED THAT THE MANUAL DRAIN OF 3000MLS OCCURRED ON (B) (5) 2007, NOT (B) (6) 2008. THE RN STATED THAT THIS INCIDENT WAS WELL DOCUMENTED IN HER FILES. ACCORDING TO THE RN, THE HP DISCONTINUED HOMECHOICE THERAPY EARLY BEFORE DRAINING OUT THE PROGRAMMED FILL VOLUME OF 2500MLS AND NEVER RECEIVED THE LAST FILL OF 2000MLS. THE HP WAS NOT ACCUSTOMED TO CARRYING 2500MLS DURING THE DAY, FELT UNCOMFORTABLE AND CONTACTED THE RN. THE HP WENT TO THE DIALYSIS CENTER AND THE RN MANUALLY DRAINED 3000MLS OF FLUID. THE RN STATED THAT THE 3000MLS OF FLUID WAS THE EXPECTED AMOUNT OF FLUID TO BE DRAINED FOR A HP WITH A FILL VOLUME OF 2500MLS. ACCORDING TO THE RN, THERE WAS NO PT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1