BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4170837 · Received October 14, 2014

    Report

    Report Number
    1416980-2014-35837
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BAXTER HEATHCARE 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

    COMPLAINT NO: (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 PERITONITIS. THE CAUSE OF THE EVENT WAS UNKNOWN. TREATMENT FOR PERITONITIS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649696 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other TRANSFER SET, TITANIUM ADAPTER, DIANEAL 2.5%