BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3863548 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18491
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 17, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO SAMPLE EVALUATION OR BATCH REVIEW COULD BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJECTION (INJ)VANCOMYCIN (2 GRAM), INJ FORTUM (1 GRAM) AND INJ HEPARIN (2 ML) (FREQUENCY AND ROUTE NOT REPORTED) FOR THE PERITONITIS. THE PATIENT IS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS ON AN UNREPORTED DATE. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338037 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 2.5% DIANEAL PD2 ULTRABAG.| 1.5% DIANEAL PD2 ULTRABAG,