BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4210625 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37894
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    March 1, 2010
    Report Date
    October 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 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 MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT WAS TREATED WITH VANCOMYCIN (INTRAPERITONEALLY, FOR TWO WEEKS, DOSE AND FREQUENCY NOT REPORTED) AND GENTAMYCIN (INTRAPERITONEALLY, FOR TWO WEEKS, DOSE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT THE PATIENT HAD RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692443 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DIANEAL PD4 AMBUFLEX, DIANEAL ULTRABAG| TRANSFER SET, CASSETTE, HOMECHOICE