BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1914894 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06558
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 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). THE DEVICE HAS NOT YET BEEN RECEIVED BUT AN EVALUATION IS EXPECTED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOG WAS DETERMINED TO BE OFF CYCLER EXCHANGE. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED HE FELT SOME DISCOMFORT AND DID A MANUAL DRAIN, DRAIN VOLUME (DV) 4800ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF HE CALLED BAXTER OR THE REGISTERED NURSE (RN) ABOUT THE ISSUE AND THE HP STATED NO. THE TSR ASKED THE HP HOW HE FELT AND THE HP STATED FINE. THE HP STATED THE HC DISPLAYED DWELL 1 OF 4. THE TSR EXPLAINED TO THE HP THAT THE HC WOULD BE SWAPPED AND RECOMMENDED THAT HP CONTACT THE RN ABOUT HOW HE WAS FEELING AND THE HC BEING SWAPPED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF HIGH DRAIN. THE PDN VERIFIED THE HP'S LARGEST PRESCRIBED FILL VOLUME (LPFV) IS 2500ML. THE PDN STATED THE HP HAS NOT REPORTED ANY SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS.

    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 71 YR