BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4221578 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38585
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 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

    COMPLAINT NO: (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS AND/OR A BATCH REVIEW COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS A GASTROINTESTINAL INFECTION. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN (1 GRAM, STAT, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) AND INJECTION FORTUM (1 GRAM, ONCE A DAY, ROUTE AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. THE PATIENT WAS RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702571 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention DIANEAL 1.5% AND 2.5% ULTRABAG| TRANSFER SET, TITANIUM ADAPTER