BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2111955 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-07020
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRAPERITONEAL VOLUME (IIPV) THAT WAS DISCOVERED DURING EVALUATION. BASED ON A REVIEW OF ALL AVAILABLE THERAPY LOG DATA, THE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN-ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM THE 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 (B)(4).

    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.

    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) 2011 DURING DRAIN CYCLE 4. THE PATIENT'S DRAIN VOLUME WAS 4396ML. THE FILL VOLUME WAS 2500ML; THIS MEETS IIPV CRITERIA. PRODUCT SURVEILLANCE LEFT A DETAILED MESSAGE WITH THE NURSE ON (B)(4) 2011 TO NOTIFY HER OF THE EVENT FOUND DURING EVALUATION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR