BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4203057 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37555
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 21, 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
    GA, US
    Reporter Occupation
    NURSE

    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 ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE EVENT WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH VANCOMYCIN (1G, EVERY FOUR DAYS, INTRAPERITONEALLY) FOR PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER FIVE DAYS. DIANEAL THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682401 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R FLEXICAP, TRANSFER SET, HOMECHOICE, CASSETTE| DIANEAL