BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3873516 · Received June 14, 2014

    Report

    Report Number
    1416980-2014-18999
    Event Type
    Injury
    Date Received
    June 14, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS THE PATIENT CAUSING A TOUCH CONTAMINATION DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED BACTERIAL PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) AND FORTAZ (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS ALSO RETRAINED ON ASEPTIC TECHNIQUE. THE FOLLOWING MONTH AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED AS THE PERITONITIS HAD NOT RESOLVED. ON AN UNREPORTED DATE, THE PD CATHETER WAS REMOVED DUE TO PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL EIGHT DAYS LATER. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE PD THERAPY WAS DISCONTINUED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351729 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R DIANEAL 1.5% PD4 ULTRABAG| DIANEAL 1.5% PD4 AMBUFLEX