BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1053488 · Received May 28, 2008

    Report

    Report Number
    1423500-2008-00424
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    February 22, 2008
    Report Date
    May 19, 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: HOMECHOICE CYCLER UNIT WAS EVALUATED IN THE PRODUCT ANALYSIS LAB. BASED ON THE EVENT LOG DATA THE EVALUATION HAS DETERMINED THE MOST PROBABLE CAUSE OF THE OVER FILL TO BE INSUFFICIENT DRAIN / FALSE EMPTY DETECT AND USE ERROR. INITIAL DRAIN ALARM SETTING INAPPROPRIATELY PROGRAMMED (TOO LOW). THE EVALUATION DID NOT CONFIRM ANY FAILURE OF MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, OVERFILL WAS IDENTIFIED IN THE EVENT LOG IN 2008 IN DRAIN CYCLE 2. PER THE LOG, THE PATIENT'S ULTRAFILTRATION READING WAS 791ML INDICATING THE HOME PATIENT (HP) DRAINED 791ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION GIVES A TOTAL DRAIN VOLUME OF 2791ML (2000ML + 791ML) WHICH IS GREATER THAN 1.3 TIMES THE LAST VOLUME INFUSED (2000ML). THE PATIENT'S NURSE WAS CONTACTED BY BAXTER. THE EVALUATION RESULT OF OVERFILL DETECTED THE SAME DAY, WAS REPORTED. THE NURSE SAID THAT THE PATIENT HAD MENTIONED THAT SHE WAS NOT DRAINING VERY WELL. THE NURSE SAID THAT THE PT DID NOT EXPERIENCE ANY SYMPTOMS OF FULLNESS OR DISCOMFORT ASSOCIATED WITH THE INCIDENT. NO ADDITIONAL INFORMATION COULD BE OBTAINED REGARDING THIS EVENT. THE NURSE SAID THAT THE PATIENT WAS DOING VERY WELL NOW AND HAD NO PROBLEMS WITH THE NEW HOMECHOICE MACHINE.

    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