BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3122769 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13047
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE SAME PATIENT AS (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS PATIENT MADE MISTAKE/TOUCH CONTAMINATION, DID NOT WEAR A MASK AND DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD THERAPY. 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 EXPERIENCED PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS PATIENT MADE MISTAKE/TOUCH CONTAMINATION, DID NOT WEAR A MASK AND DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PERITONEAL DIALYSIS THERAPY WITH UNKNOWN BAXTER DISPOSABLES. THE PATIENT WAS HOSPITALIZED FOR THE EVENT FOR 3 DAYS. THE PATIENT WAS TREATED WITH VANCOMYCIN AND ROCEPHIN (DOSES, FREQUENCIES AND ROUTE NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET BEEN RETRAINED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224834 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R DIANEAL PD4 ULTRABAG