BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4102867 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32330
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 10, 2014
    Report Date
    September 30, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS. 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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF PERITONITIS WAS REPORTED TO BE THE USE OF A CONTAMINATED TOPICAL CREAM ON A NON-BAXTER PRODUCT. AS THE CAUSE OF THE PERITONITIS WAS DUE TO NON-BAXTER PRODUCT(S), THE BAXTER HEALTHCARE CORPORATION DISPOSABLE PRODUCT IS NO LONGER SUSPECT FOR THIS SERIOUS INJURY EVENT AND THE EVENT REMAINS A USE ERROR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH RESULTED IN THE DEVELOPMENT OF PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER SPECIFIED AS THE PATIENT DID NOT WEAR A MASK FOR THERAPY. PRIOR TO EXPERIENCING PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN INDICATION. WHILE HOSPITALIZED, THE PATIENT WAS THEN DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH ANCEF (INTRAVENOUSLY, DOSE AND FREQUENCY NOT REPORTED) FOR THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL TWELVE DAYS AFTER THE ONSET OF THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584655 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R