BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1056078 · Received June 3, 2008

    Report

    Report Number
    1423500-2008-00439
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CYCLER'S INITIAL DRAIN ALARM SETPOINT WAS PROGRAMMED TOO LOW AT 0 MLS, RESULTING IN AN INCOMPLETE INITIAL DRAIN FOLLOWED BY A FULL FILL. AS A RESULT OF THIS INCIDENT, THE INITIAL DRAIN ALARM SETPOINT WAS INCREASED FROM 0MLS TO 1500MLS. ACCORDING TO THE HP'S HEALTHCARE PROFESSIONAL, REPROGRAMMING OF THE CYCLER HAS RESOLVED THIS INCIDENT AND THE HP CONTINUES TO USE THE HOMECHOICE CYCLER WITHOUT FURTHER REPORTED DIFFICULTY. DEVICE REPROGRAMMING HAS RESOLVED THIS INCIDENT, THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT REQUIRED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REPORTED ABDOMINAL DISTENTION, AS IF HE WERE OVERFILLED WITH FLUID, DURING THERAPY USING THE HOMECHOICE AUTOMATED PERITONEAL DIALYSIS (APD) SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHICH REVEALED THE HP DRAINED 362MLS DURING THE INITIAL DRAIN WHEN THE CYCLER ADVANCED INTO DAY FILL 1. THE HP RECEIVED THE DAY FILL VOLUME OF 2000MLS AND EXPERIENCED ABDOMINAL DISTENTION. DURING THE DAY DRAIN THE HP REMOVED 3300 MLS OF FLUID, WHICH WAS 1100MLS GREATER THAN THE PROGRAMMED FILL VOLUME OF 2000 MLS. REVIEW OF THE CYCLER'S PROGRAMMING REVEALED THE HP WAS PERFORMING HI-DOSE CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD), DAY FILL VOLUME = 2000MLS, NIGHT FILL VOLUME = 2000MLS, LAST FILL VOLUME = 2000MLS, INITIAL DRAIN ALARM SETPOINT = 0MLS. THE TSR REVIEWED HOMECHOICE DRAIN LOGIC WITH THE HP AND CONTACTED THE HP'S DIALYSIS CENTER NURSE (RN). AS A RESULT OF THIS INCIDENT, THE TSR VERBALLY ASSISTED THE HP TO INCREASE THE INITIAL DRAIN ALARM SETPOINT FROM 0 MLS TO 1500 MLS. THERE WAS NO PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1