BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6125792 · Received November 23, 2016

    Report

    Report Number
    1416980-2016-17628
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 11, 2016
    Report Date
    February 14, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE WAS REPORTED AS (B)(6) (NOT FURTHER SPECIFIED) ONE DAY BEFORE PERITONITIS DIAGNOSIS THE PATIENT EXPERIENCED SYMPTOM MANIFESTATION OF ABDOMINAL PAIN. THE FOLLOWING DAY THE PATIENT WAS HOSPITALIZED FOR THE EVENT. DIANEAL THERAPY WAS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED FROM THE REPORTING HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT¿S MOTHER RECEIVED RETRAINING REGARDING PROPER CONNECT OR DISCONNECT METHOD AND PROPER ASEPTIC TECHNIQUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A 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

    A PERITONEAL DIALYSIS (PD) THERAPY EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS NOT FURTHER SPECIFIED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY, DURATION AND ROUTE NOT REPORTED) FOR THE PERITONITIS. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776488 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL