BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1082118 · Received July 25, 2008

    Report

    Report Number
    1423500-2008-00682
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    April 2, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL DISCOVERED DURING EVAL. BASED ON A REVIEW OF THE AVAILABLE THERAPY LOG DATA, THE EVAL HAS DETERMINED THE PROBABLE CAUSE OF THIS OVERFILL TO BE: INSUFFICIENT DRAIN AND MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOWING FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD SYSTEM ERROR 2431 WHICH WAS ENCOUNTERED WHILE OBTAINING THE ALARM LOG WAS CAUSED BY INTERMITTENT SOFTWARE OF THE DIGITAL PRINTED CIRCUIT BOARD (PCB). THE SYSTEM ERROR ENCOUNTERED DURING THE EVAL WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL FOUND DURING THE EVAL. THE DEVICE WILL BE ROUTED TO THE SVC AREA WHERE INTEGRATED CIRCUITS U16, U19, U26, U38 AND U42 ON THE DIGITAL PCB WILL BE SCRAPPED AS A PRECAUTIONARY MEASURE.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED IN 2008, DURING DRAIN CYCLE 5. THE PT'S ULTRAFILTRATION READING WAS 1150ML INDICATING THE HOME PT (HP) DRAINED 1150ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 1800ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 2950ML (1800ML + 1150ML). DURING A FOLLOW-UP CALL WITH WHOM WAS THE HOME PT'S (HP) NURSE, THE NURSE INDICATED THAT SHE DOES NOT HAVE ANY INFO IN REGARDS TO THIS EVENT. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION RELATED TO 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 50 YR