BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4121674 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33360
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    July 2, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 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 PERITONITIS EVENT WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. THE OUTCOME OF THE EVENT WAS NOT REPORTED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601638 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention HOMECHOICE, CASSETTE, TRANSFER SET,| TITANIUM ADAPTER