BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 5093615 · Received September 22, 2015

    Report

    Report Number
    1416980-2015-36795
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    August 31, 2015
    Report Date
    October 1, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4): ON AN UNREPORTED DATE, THE PATIENT¿S FLUID WAS CLEAR. IT WAS REPORTED THE PATIENT WAS DOING WELL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT.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 BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS AN ATTENDANT DOING CAPD WITHOUT PROPER TRAINING. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH VANCOGEN INJECTION (1 GRAM, INTRAPERITONEALLY, FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PATIENT WAS RECOVERING FROM THE EVENT, AND DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626992 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention