BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4124021 · Received September 27, 2014

    Report

    Report Number
    1416980-2014-33568
    Event Type
    Injury
    Date Received
    September 27, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED CLOUDY EFFLUENT AND A FEVER. THE CAUSE OF THE EVENTS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH UNSPECIFIED MEDICATION. THE OUTCOME OF THE EVENTS IS UNKNOWN. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603445 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TRANSFER SET, TITANIUM ADAPTER,| DIANEAL 1.5% AND 2.5% AMBUFLEX