BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4200729 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37343
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 28, 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). IT WAS REPORTED DURING FOLLOW UP THAT THE ANTIBIOTIC THERAPY WAS DISCONTINUED AND THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT (PREVIOUSLY UNKNOWN). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. (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 UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH REFLIN INJECTION 1000 MILLIGRAMS (ROUTE, FREQUENCY, AND DURATION NOT REPORTED) AND AMIKACIN INJECTION 125 MILLIGRAM (ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERING OR WAS RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679924 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R DIANEAL 1.5% ULTRABAG| TRANSFER SET, TITANIUM ADAPTER