BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4141201 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34469
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 31, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EXTENSION SET. 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, MANIFESTED BY CLOUDY EFFLUENT, COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND BEGAN TREATMENT WITH VANCOMYCIN (INTRAPERITONEALLY, DAILY, DOSE NOT REPORTED) FOR PERITONITIS. EIGHT DAYS AFTER BEING HOSPITALIZED, THE PATIENT WAS DISCHARGED. THE CAUSE OF THE EVENT WAS UNKNOWN. DIANEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, TREATMENT WITH VANCOMYCIN WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619656 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION H1421099

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R DIANEAL PD4 1.5% AMBUFLEX,| HOMECHOICE, TRANSFER SET| DIANEAL ULTRABAG PD4 1.5% , CASSETTE, MINICAP