BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1040661 · Received May 9, 2008

    Report

    Report Number
    1423500-2008-00328
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER REQUESTED THE DEVICE FOR EVAL; HOWEVER, THE CUSTOMER DECLINED TO MAKE THE DEVICE AVAILABLE.

    Description of Event or Problem · 1

    THE NURSE (RN) OF A HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REPORTED THE HP FELT ABDOMINAL BLOATING AND DISCOMFORT, AS IF HE WERE OVERFILLED WITH FLUID, USING THE HOMECHOICE PRO AUTOMATED PERITONEAL DIALYSIS (APD) SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE HP DRAINED OUT 1800 MLS DURING THE APD THERAPY INITIAL DRAIN, WHICH WAS 800 MLS GREATER THAN THE CYCLER'S PROGRAMMED LAST FILL VOLUME OF 1000 MLS. ACCORDING TO THE RN, THE APD CYCLER WAS PROGRAMMED FOR 6 CYCLES OF 3000 MLS WITH A LAST FILL VOLUME OF 1000 MLS. THE RN SUSPECTED THE ADDITIONAL 800 MLS OF FLUID DRAINED WAS EITHER ACTUAL ULTRAFILTRATION REMOVED FROM THE HP'S BODY FROM NORMAL PERITONEAL DIALYSIS THERAPY OR AN INCOMPLETE DRAIN PRIOR TO THE RECEIPT OF THE LAST FILL. CYCLER DRAIN LOGIC, MOVE-ON CRITERIA FROM DRAIN TO FILL AND THE LAST MANUAL DRAIN FEATURE WAS REVIEWED WITH THE RN. THE RN HAS NOT MADE ANY THERAPY CHANGES AS A RESULT OF THIS INCIDENT, SINCE THE HP HAS NOT SHOWN UP TO CLINIC RECENTLY. THE RN STATES THAT IF THE HP CONTINUES TO EXPERIENCE ABDOMINAL BLOATING AND/OR DISCOMFORT, SHE MAY INCREASE THE CYCLER'S MINIMUM DRAIN VOLUME FROM 85% TO 100% AND IMPLEMENT A LAST MANUAL DRAIN. 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 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTRANEAL| 2.5% LO/CAL 6L DIANEAL| 1.5% LO/CAL 6L DIANEAL