BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6061573 · Received October 27, 2016

    Report

    Report Number
    1416980-2016-16721
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PERITONITIS OCCURRED ¿APPROXIMATELY 4 DAYS AGO FROM (B)(6) 2016¿. (B)(6). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PEDIATRIC PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT. ACTION WITH DIANEAL THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711472 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R CASSETTE| DIANEAL 3.86%| HOMECHOICE