BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1935786 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07141
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 29, 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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS CLINIC. THE RECEPTIONIST STATED THE NURSE WAS NOT IN. A VOICEMAIL WAS LEFT EXPLAINING AN IIPV WAS FOUND DURING EVALUATION, THE DATE, VOLUME AND CAUSE. DEVICE EVALUATION: THE HOMECHOICE (HC) WAS EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE PASSED BOTH THE RETURNED INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL AND ELECTRICAL TESTS. THE ASSIGNABLE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME WAS DETERMINED TO BE AN INSUFFICIENT DRAIN (ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN A SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. REVIEW OF THE SERVICE HISTORY REVEALS THE DEVICE PASSED ALL TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM BAXTER. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE IIPV. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    AN INSTANCE OF INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING A REVIEW OF THE RETURNED HOMECHOICE (HC) PATIENT EVENT LOG. ON (B)(6) 2010, THE ULTRAFILTRATION VOLUME WAS 69ML DURING CYCLE 5.

    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 HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)