BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4182092 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36318
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 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. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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 UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTION REFLIN (1G, FREQUENCY AND ROUTE NOT REPORTED), INJECTION FORTUM (1G, FREQUENCY AND ROUTE NOT REPORTED) AND INJECTION AMIKACIN (100MG PER DAY FOR ONE BAG; ROUTE NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661277 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R DIANEAL 2.5% ULTRABAG| TRANSFER SET, TITANIUM ADAPTER,