BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1031553 · Received April 18, 2008

    Report

    Report Number
    1423500-2008-00266
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BY BAXTER QUALITY MANAGEMENT FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED AT CANADIAN TECHNICAL SERVICES. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE REGISTERED NURSE (RN) OF A PT CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REPORTED THE PT FELT OVERFILLED WITH FLUID DURING FILL 1 USING THE HOMECHOICE SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE PT WAS BEING DIALYZED AT THE HOSPITAL AT THE TIME OF THE RN'S CALL, AND THE PT'S LAST FILL VOLUME WAS 2500MLS. THE RN REPORTED THE PT FELT ABDOMINAL PAIN, DISTENTION, DISCOMFORT AND BLOATING DURING FILL 1. THE HOMECHOICE SYSTEM WAS PLACED INTO A MANUAL DRAIN AND THE PT DRAINED 725MLS. AFTERWARDS, THE PT WAS DISCONNECTED FROM THE SYSTEM AND DRAINED AN ADD'L 5800MLS USING MANUAL CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) SUPPLIES. ACCORDING TO THE RN, A RESPIRATORY ARREST EMERGENCY WAS CALLED FOR THE PT. THE NURSE OF THE PT REQUESTED A REPLACEMENT CYCLER. THE TSR SUBSEQUENTLY SWAPPED THE PT'S CYCLER. FOLLOW UP WITH THE RN IN 2008 REVEALED THE PT WAS ADMITTED TO THE ACUTE WARD WHERE HE WAS TREATED FOR PYELONEPHRITIS. THE RN BELIEVES THE INCIDENT WAS DUE TO THE HOME CHOICE DEVICE. THE PT IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention