BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4200727 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37340
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 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. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH AN INTRAPERITONEAL INJECTION OF VANCOMYCIN (1G STAT DOSE) AND INTRAVENOUS INJECTIONS OF TAZACT (4.5G TWICE DAILY, DURATION NOT REPORTED) FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680298 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DIANEAL PD2 1.5% AND 2.5% ULTRABAG SOLUTIONS| TITANIUM ADAPTER, TRANSFER SET