BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1812808 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02819
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE DEVICE HAS BEGUN, HOWEVER, HAS NOT YET BEEN COMPLETED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRAPERITONEAL VOLUME (IIPV) THAT WAS FOUND IN THE DEVICE LOGS. THE CAUSE OF THE IIPV WAS DETERMINED TO BE: FALSE EMPTY DETECT AND USE ERROR DUE TO INAPPROPRIATE BYPASSING OF THE LOW DRAIN VOLUME ALARM AND SECONDARILY INSUFFICIENT DRAIN AS ONE OR MORE CYCLES ADVANCED TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. LABELING REVIEW FOUND THE LABELING TO BE SUFFICIENT FOR THE USE ERROR IDENTIFIED IN THIS REPORT. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE PATIENT'S DRAIN VOLUME WAS 3597ML. THE LARGEST PRESCRIBED FILL VOLUME WAS 2000ML. THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE THE PATIENT HAS NOT REPORTED ANY SYMPTOMS OF OVERFILL. THE NURSE STATED THAT THE PATIENT HAS BEEN SEEN SINCE AND IS DOING WELL. THE NURSE STATED THAT THE PATIENT MAY HAVE OVERFILLED DURING A MIDDAY EXCHANGE WHICH SHE DOES NOT DO VERY OFTEN. THE PATIENT RESUMED THERAPY WITHOUT PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR