BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2132166 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07742
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    December 22, 2010
    Report Date
    May 26, 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
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE CAUSE FOR THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN - ONE OR MORE CYCLE ADVANCES TO NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SIMILAR REPORTS HAVE BEEN RECEIVED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA RTB-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE HAS BEEN RECEIVED BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A SINGLE INSTANCE OF INCREASED INTRAPERITONEAL VOLUME(IIPV) WAS FOUND WITHIN THE EVENT LOGS DURING THE DEVICE EVALUATION. ACCORDING TO THE EVENT LOGS, THE EVENT OCCURRED ON 22DEC2010 AT 08:36:20 WITH A DRAIN VOLUME (DV) OF 4128ML DURING CYCLE 3.

    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 63 YR LOCAL (PD4)AMBUFLEX| LOCAL(PD4)ULTRABAG