BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4131309 · Received October 1, 2014

    Report

    Report Number
    1416980-2014-33981
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 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). ON AN UNREPORTED DATE, THE PERITONITIS WAS RESOLVED AND THE PATIENT WAS RECOVERED FROM THE EVENT (PREVIOUSLY UNKNOWN). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (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; THEREFORE, A DEVICE ANALYSIS 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 (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN INJECTION 2 GRAM ONCE INTRAPERITONEALLY (IP) (ADDITIONAL FREQUENCY AND DURATION NOT REPORTED), FORTUM 1 GRAM DAILY UP TO 14 DAYS IP, AND HEPARIN 2 MILLILITER PER EVERY EXCHANGE (DOSAGE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERING OR WAS RECOVERED FROM THE PERITONITIS EVENT. 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
    611418 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DIANEAL 2.5% ULTRABAG PD2| TRANSFER SET, TITANIUM ADAPTER