BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1071771 · Received July 7, 2008

    Report

    Report Number
    1423500-2008-00614
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    March 15, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE EVALUATION HAS DETERMINED THE MOST PROBABLE CAUSE OF THIS OVERFILL TO BE: INSUFFICIENT DRAIN AND MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    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 859ML INDICATING THE HOME PATIENT (HP) DRAINED 859ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2500ML. THIS INFORMATION GIVES A TOTAL DRAIN VOLUME OF 3359ML (2500ML + 859ML). DURING A FOLLOW-UP CALL WITH WHOM WAS THE PATIENT'S NURSE WHILE THE PATIENT WAS ON PERITONEAL DIALYSIS, THE NURSE STATED THAT SHE DID NOT RECALL THE PATIENT EXPERIENCING ANY SYMPTOMS OF FULLNESS OR DISCOMFORT ASSOCIATED WITH THE INCIDENT. THE NURSE INDICATED THAT SHE DID NOT HAVE ANY ADDITIONAL INFORMATION AVAILABLE AS THE PATIENT'S CHART IS NO LONGER AVAILABLE SINCE THE PATIENT HAS SWITCHED TO HEMODIALYSIS THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT OR DURING THE FOLLOW-UP CALL WITH THE NURSE.

    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 80 YR