BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4130706 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33952
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED PERITONITIS, WAS HOSPITALIZED FOR THE EVENT AND DISCHARGED FROM THE HOSPITAL ON UNREPORTED DATES IN (B)(6) 2014. THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY WHICH CAUSED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED FOR THE PERITONITIS WITH UNKNOWN ANTIBIOTICS. ON AN UNREPORTED DATE, THE PATIENT WAS RECOVERING FROM THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607888 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4, 2.5% & 4.25%, HOMECHOICE