BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4150275 · Received October 7, 2014

    Report

    Report Number
    1416980-2014-34942
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    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 PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER.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 EVEN ON AN UNREPORTED DATE. THE PATIENT WAS TREATED WITH VANCOMYCIN (500MG, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) AND AMIKACIN (250MG, ONCE DAILY, ROUTE AND DURATION NOT REPORTED) FOR PERITONITIS. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE PATIENT OUTCOME WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629668 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R TRANSFER SET, MINICAP, AND DIANEAL 2.5% ULTRABAG.