BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4230684 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39085
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED FOR THE PERITONITIS WITH NETILMICIN (50 MILLIGRAMS, FREQUENCY AND ROUTE OF ADMINISTRATION NOT REPORTED) AND TARGOCID (400 MG, FREQUENCY AND ROUTE OF ADMINISTRATION NOT REPORTED) INJECTIONS. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT, DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714327 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention DIANEAL 2.5% ULTRABAG,| TITANIUM ADAPTER, TRANSFER SET