BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4152879 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-35037
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    BAXTER HEALTHCARE 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 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 PERITONITIS IS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. TREATMENT WAS NOT REPORTED FOR THIS EVENT. AT THE TIME OF THIS REPORT, IT IS UNKNOWN WHAT THE PATIENT OUTCOME IS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631105 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other 2.5% DIANEAL PD2 ULTRABAG| TITANIUM ADAPTER, TRANSFER SET,| 1.5% DIANEAL PD2 ULTRABAG,