BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1082462 · Received July 22, 2008

    Report

    Report Number
    1423500-2008-00675
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 2, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). BAXTER REQUESTED THE DEVICE FOR EVALUATION; HOWEVER, THE CUSTOMER DECLINED TO MAKE THE DEVICE AVAILABLE. BASED ON A REVIEW OF ALL AVAILABLE THERAPY DATA, THE MOST PROBABLE CAUSE OF THE OVERFILL WAS DETERMINED TO BE: INSUFFICIENT DRAIN/FALSE EMPTY DETECT AND USE ERROR. INITIAL DRAIN ALARM SETTING INAPPROPRIATELY SET TOO LOW (SET AT 100MLS). THE INITIAL DRAIN ALARM SETPOINT MAY HAVE BEEN PROGRAMMED TO LOW, RESULTING IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A PARTIAL FILL OF SOLUTION. THE PROBABLE CAUSE OF THE OVERFILL WAS COMMUNICATED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REQUESTED ASSISTANCE WITH A MANUAL DRAIN DURING FILL 1 USING THE HOMECHOICE SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE HP HAD RECEIVED A PARTIAL FILL OF 898MLS AT THE TIME OF THE CALL. THE TSR VERBALLY ASSISTED THE CALLER TO PERFORM A MANUAL DRAIN AND 1224MLS OF FLUID WAS REMOVED, WHICH WAS 326MLS GREATER THAN THE VOLUME OF FLUID THE HP HAD JUST RECEIVED. THE HP INDICATED THAT HE HAD NOT COMPLETELY DRAINED DURING THE INITIAL DRAIN PRIOR TO THE SYSTEM ADVANCING INTO FILL 1. REVIEW OF THE THERAPY REVEALED THE LAST FILL VOLUME WAS 300MLS, THE INITIAL DRAIN ALARM SETPOINT WAS 100MLS AND THE PATIENT HAD DRAINED 226MLS DURING THE INITIAL DRAIN. THE TSR EXPLAINED THE THERAPY TO THE HP AND THE HP EXPRESSED UNDERSTANDING. FILL 1 RESUMED AND THERAPY CONTINUED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORTED INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1