BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1052854 · Received May 27, 2008

    Report

    Report Number
    1423500-2008-00413
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    December 5, 2007
    Report Date
    April 30, 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

    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 ALL AVAILABLE THERAPY LOG DATA, THE EVAL HAS DETERMINED THE MOST PROBABLE CAUSE IS: INSUFFICIENT DRAIN/FALSE EMPTY DETECT AND USE ERROR, INITIAL DRAIN ALARM INAPPROPRIATELY PROGRAMMED AND/OR INSUFFICIENT DRAIN/MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. IT WAS NOTED IN THE EVENT LOG THAT THE PT HAD BEEN DRAINING LESS THAN THE FILL VOLUME IN PREVIOUS CYCLES OF THIS THERAPY SESSION, WHICH COULD HAVE CONTRIBUTED TO THE INCREASED DRAIN VOLUME IN DRAIN 5. THE DEVICE WILL BE ROUTED TO THE SVC AREA.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, A POSSIBLE OVERFILL SITUATION WAS IDENTIFIED WHICH OCCURRED IN LATE 2007, DURING DRAIN CYCLE 5. THE PT'S ULTRAFILTRATION READING WAS 994ML INDICATING THE HOME PT (HP) DRAINED 994ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2300ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 3294ML (2300ML + 994ML). DURING A FOLLOW-UP CALL WITH THE HOME PT'S (HP) NURSE, THE NURSE STATED THAT THE HP DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF FULLNESS OR DISCOMFORT ASSOCIATED WITH THE INCIDENT. THE NURSE DID NOT HAVE ANY ADD'L INFO. HOWEVER, THE NURSE DID INDICATE THAT THE HP IS DOING FINE AND HAS BEEN ABLE TO CONTINUE PERITONEAL DIALYSIS THERAPY WITHOUT ANY FURTHER PROBLEMS. NO PT 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 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED 78FKK FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1