BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4201353 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37412
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: UNKNOWN DATE IN (B)(6) 2014 THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S WHITE BLOOD CELL COUNT (WBC) WAS ¿OFF¿ (DETAILS NOT PROVIDED) COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED MEDICAL CONDITION. THE PATIENT WAS TREATED WITH INTRAPERITONEAL TAZICEF (NIGHTLY FOR TWO WEEKS; DOSE NOT REPORTED) AND INTRAPERITONEAL CEFAZOLIN (NIGHTLY FOR TWO WEEKS; DOSE NOT REPORTED) FOR ¿LOW WBC¿. THE OUTCOME WAS NOT REPORTED. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE CAUSE OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684581 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL 2.5%, DIANEAL 4.25%, LASIX,| TRANSFER SET, TITANIUM ADAPTER, CASSETTE