BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1070505 · Received July 1, 2008

    Report

    Report Number
    1423500-2008-00580
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    March 18, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL INCIDENT. BASED ON A REVIEW OF ALL AVAILABLE DEVICE LOG DATA, THE MOST PROBABLE CAUSE OF THE OVERFILL WAS DETERMINED TO BE: INSUFFICIENT DRAIN / FALSE EMPTY DETECT AND USE ERROR. INAPPROPRIATELY SET TOTAL ULTRAFILTRATION (UF) TOO LOW (SET AT 0). THEREFORE, IT IS POSSIBLE THAT THE HP DRAINED ONLY THE PROGRAMMED TIDAL VOLUME DURING THE FIRST 3 CYCLES AND DRAINED THE ACCUMULATED ULTRAFILTRATION VOLUME DURING DRAIN 4. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA. THE DEVICE EVALUATION RESULTS WERE REVIEWED WITH THE NURSE (RN). THE RN AGREES THAT INCORRECT PROGRAMMING OF THE CYCLER MAY HAVE CAUSED THIS INCIDENT. THE CYCLER WAS PROGRAMMED FOR A TOTAL UF OF 0MLS WITHOUT ANY FULL DRAINS. THE RN RELATES THE HP'S CYCLER WAS SUPPOSE TO BE PROGRAMMED FOR A TIDAL THERAPY WITH A TOTAL UF OF 0MLS. HOWEVER, IT ALSO SHOULD HAVE BEEN PROGRAMMED FOR FULL DRAINS EVERY 2 CYCLES. ACCORDING TO THE RN, IT IS THE POLICY OF THE DIALYSIS FACILITY TO PROGRAM THE CYCLER FOR FULL DRAINS EVERY 2 CYCLES DURING TIDAL THERAPIES WITH A TOTAL UF OF 0MLS TO ENSURE PERIODIC REMOVAL OF THE PATIENT'S UF DURING THERAPY. SINCE THE CYCLER WAS NOT PROGRAMMED FOR ANY FULL DRAINS AND TOTAL UF = 0MLS, THE ULTRAFILTRATION MAY HAVE ACCUMULATED UNTIL CYCLE 4 DRAIN.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED IN 2008 DURING DRAIN CYCLE 4. THE PATIENT'S ULTRAFILTRATION READING WAS 1331MLS, INDICATING THE HOME PATIENT (HP) DRAINED 1331MLS MORE THAN THE TIDAL FILL VOLUME OF 2375MLS. THIS INFORMATION GIVES A TOTAL DRAIN VOLUME OF 3706MLS (1331MLS + 2375MLS). THE HP IS DOING FINE AND HAS BEEN ABLE TO CONTINUE PERITONEAL DIALYSIS THERAPY WITHOUT ANY FURTHER PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DESPITE BAXTER'S ATTEMPTS, NO ADDITIONAL INFORMATION COULD BE OBTAINED REGARDING THIS EVENT.

    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