BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1963074 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00747
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    November 3, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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 INTRA-PERITONEAL VOLUME (IIPV) THAT WAS FOUND IN THE DEVICE LOGS. THE CAUSE WAS DETERMINED TO BE: INSUFFICIENT DRAIN-ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE IIPV. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RTB-CAPA-(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 13. THE PATIENT'S ULTRAFILTRATION READING WAS 64ML, INDICATING THE HOME PATIENT (HP) DRAINED 64ML MORE THAN THEIR PROGRAMMED FILL VOLUME OF 200ML. THIS INFORMATION MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON 01/18/2011. ACCORDING TO THE NURSE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE NURSE STATED THAT THE PATIENT HAS RESUMED THERAPY SUCCESSFULLY. THE PATIENT WILL BE DISCONTINUING THERAPY IN THE NEAR FUTURE AS THE PATIENT IS RECEIVING A TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO