BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3802943 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15009
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS BREAK IN ASEPTIC TECHNIQUE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING UNKNOWN BAXTER PD DISPOSABLES, WHICH CAUSED PERITONITIS. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AS THE ONSET OF PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTIONS OF VANCOMYCIN (1 GM, INTRAPERITONEALLY (IP), LOADING DOSE), INJECTIONS OF FORTUM (1 GM, IP, FREQUENCY NOT REPORTED) AND INJECTIONS OF AMIKACIN (125 MG, ONCE DAILY) FOR PERITONITIS. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280464 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R DIANEAL PD2 1.5% AND 2.5% ULTRABAG