BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3893111 · Received June 25, 2014

    Report

    Report Number
    1416980-2014-20216
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE REPORTED IIPV CONDITION. THE CAUSE WAS NOT ABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED DURING DRAIN CYCLE FOUR. THIS EVENT OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2014 23:43:59. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370356 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE