BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4112293 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32952
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A BREAK 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

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, RESULTING IN PERITONITIS. THE BREACH WAS FURTHER DESCRIBED AS TOUCH CONTAMINATION. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN (1G, INTRAPERITONEALLY, FREQUENCY AND DURATION WAS UNKNOWN), AND GENTAMICIN (160MG, INTRAPERITONEALLY, FREQUENCY AND DURATION WAS UNKNOWN) FOR PERITONITIS. WHILE HOSPITALIZED, THE PATIENT¿S PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS THERAPY. THE PATIENT WAS DISCHARGED AFTER EIGHT DAYS. HEMODIALYSIS WAS ONGOING AT THE TIME OF THIS REPORT. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592615 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R 4.25% AND 2.5% SINGLEBAG