BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3230661 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18734
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS DID NOT WEAR A MASK, DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. THE PATIENT MADE A MISTAKE OF TOUCH CONTAMINATION. ONE DAY AFTER EXPERIENCING THE PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS RE-TRAINED IN PROPER ASEPTIC TECHNIQUE FOR PD THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330188 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization EXTRANEAL| DIANEAL