BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4123821 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33555
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER: TELEPHONE NUMBER PROVIDED WAS (B)(6). 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. THIS IS THE SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. 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. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON THE SAME DAY, THE PATIENT BEGAN TREATMENT WITH INJECTION (INJ) VANCOMYCIN (1G IMMEDIATELY, THEN EVERY FOUR DAYS FOR ONE WEEK; ROUTE NOT REPORTED) AND INJ FORTUM (1G IMMEDIATELY, THEN NIGHTLY FOR FOURTEEN DAYS; ROUTE NOT REPORTED) FOR PERITONITIS. DIANEAL THERAPY WAS ONGOING. THE OUTCOME OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602464 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention DIANEAL 2.5%.| TRANSFER SET, TITANIUM ADAPTER