BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1021883 · Received March 28, 2008

    Report

    Report Number
    1423500-2008-00191
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    January 13, 2008
    Report Date
    March 18, 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

    THREE SIMULATED PT THERAPIES WERE PERFORMED USING THE PT'S THERAPY SETTINGS. DURING THESE THERAPIES, NO PROBLEMS WERE ENCOUNTERED. SOFTWARE WAS THEN USED TO MONITOR THE DEVICE'S PNEUMATIC SYSTEM. NO PROBLEMS WERE REVEALED AND ALL PRESSURES WERE CORRECT AND STABLE. THE COVER WAS OPENED AND AN INTERNAL INSPECTION PERFORMED; NO PROBLEMS WERE REVEALED DURING THIS INSPECTION AND ALL CONNECTIONS WERE CORRECT AND SECURE. A REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO PAST TRENDS. THE EVENT THERAPY, AND ALARM LOGS WERE DOWNLOADED. THE EVENT LOG CONTAINED DATA FROM 2008 AND CONTAINED NO DEVICE RELATED ANOMALIES. THE LOG RECORDED NUMEROUS LOW DRAIN VOLUME ALARMS. A REVIEW OF THE DEVICE'S CYCLE-BY-CYCLE UF LOG REVEALED 2 INSTANCES OF POSSIBLE OVERFILLS (THERAPIES STARTED EARLY 2008 DURING DRAIN 4, AND ON THREE DAYS LATER DURING DRAIN 2). THE THERAPY LOG CONTAINED INFO FROM THAT MONTH AND CONTAINED NO DEVICE ANOMALIES. PER THE LOG, THERE WAS NO THERAPY STARTED ON THE SAME MONTH AND THE THERAPY STARTED ON THE NEXT DAY WAS INCOMPLETE. THE THERAPIES STARTED ON THE SAME MONTH BOTH HAD POSITIVE TOTAL ULTRAFILTRATIONS (UF), AND THE LAST 2 THERAPIES BOTH HAD NUMEROUS BYPASSES AND MANUAL DRAINS. THE ALARM LOG CONTAINED ALARMS FROM THAT MONTH, AND CONTAINED NO DEVICE ANOMALIES. THE LOG CONTAINED NUMEROUS LOW DRAIN VOLUME ALARMS. A LOW DRAIN VOLUME ALARM IS AN AUTO RESTART ALARM. THIS ALARM WILL OCCUR WHEN A LOW-FLOW AND/OR NO-FLOW CONDITION OCCURRED BEFORE THE PROGRAMMED MINIMUM DRAIN VOLUME PERCENT (OR INITIAL DRAIN VOLUME) WAS COMPLETED. THIS IS MOST LIKELY DUE TO CATHETER ISSUES OR POSITIONING. THIS EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. DRAINING ISSUES/LOW DRAIN VOLUME ALARM: MOST PROBABLE CAUSE IS THERAPY RELATED ISSUES, CATHETER ISSUES, AND CATHETER POSITIONING RESULTING IN FLUID POCKETING. THIS EVAL HAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE OVERFILLS DISCOVERED DURING EVAL IS DUE TO INSUFFICIENT DRAIN WHEN MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE MACHINE, AN OVERFILL SITUATION WAS IDENTIFIED IN THE CYCLE BY CYCLE ULTRAFILTRATION (UF) LOG IN 2008, DRAIN CYCLE 4. PER THE LOG, THE PT'S UF READING WAS 845 ML INDICATING THE HOME PT (HP) DRAINED 845 ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 2000 ML. THIS INFO GIVES A TOTAL DRAIN VOLUME OF 2845 ML (2000 ML + 845 ML). BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA COMBINED WITH AVAILABLE DECISION TREE INFO, PAL HAS DETERMINED THE MOST PROBABLE CAUSE OF THESE OVER FILLS TO BE INSUFFICIENT DRAIN WHEN MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MAIN DRAIN VOLUME THRESHOLD. DURING A FOLLOW-UP CALL WITH THE HOME PT'S (HP) WIFE ON TWO AND A HALF MONTHS LATER, NEITHER THE HP NOR THE HP'S WIFE RECALLED THE SPECIFIC INCIDENT BUT DID SAY THAT WITH THIS HOMECHOICE (HC) UNIT, THEY HAD BEEN HAVING VARIOUS LOW DRAIN VOLUME ALARMS, HAVING TO BYPASS SOME, AND THEY WOULD SEE THE DRAIN VOLUMES FLUCTUATING AND THE HC UNIT GOING FROM ONE DRAIN CYCLE TO ANOTHER, IN NO PARTICULAR ORDER. THE HP DID NOT EXPERIENCE ANY SYMPTOMS OF DISCOMFORT OR FULLNESS. NEITHER THE HP'S WIFE NOR THE HP HAD ANY ADD'L INFO. HOWEVER, THE HP IS REPORTEDLY DOING FINE AND HAS BEEN ABLE TO CONTINUE PERITONEAL DIALYSIS THERAPY ON THEIR REPLACEMENT HC UNIT 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 HP'S WIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1