BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3951144 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23722
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED A FEVER AND CLOUDY PD EFFLUENT. FEW WEEKS PRIOR TO THE RECEIPT OF THIS REPORT, THE PT UNDERWENT A CATHETERIZATION (UNSPECIFIED). ON AN UNREPORTED DATE, THE PT WAS HOSPITALIZED FOR THE FEVER AND CLOUDY PD EFFLUENT EVENT. TREATMENT FOR THE EVENTS WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PT WAS DIAGNOSED WITH PERITONITIS. THE OUTCOME FOR THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428482 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization NEAL PD2, 1.5% AMBUFLEX| NEAL PD2, 2.5% AMBUFLEX