BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4052071 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29247
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. 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).

    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. NINE DAYS AFTER ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN (DOSE AND FREQUENCY UNKNOWN, DURATION NOT REPORTED) AND IP ANCEF (DOSE AND FREQUENCY UNKNOWN, DURATION NOT REPORTED) FOR THE PERITONITIS. THE PATIENT WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL AND REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534009 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R DIANEAL, TITANIUM ADAPTER, MINICAP, CASSETTE