BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3033711 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08311
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS. TREATMENT FOR PERITONITIS INCLUDED AN UNSPECIFIED ANTIBIOTIC. THE PATIENT HAD DEVELOPED PERITONITIS DURING HER HOSPITALIZATION FOR SEIZURES. THE CAUSE OF PERITONITIS WAS CONTAMINATION/BREACH IN ASEPTIC TECHNIQUE. IT WAS NOT REPORTED IF RETRAINING ON PROPER ASEPTIC TECHNIQUE WAS PERFORMED WITH THE PATIENT. THE PATIENT'S PD CATHETER WAS REMOVED, AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS (HD). AT THE TIME OF THIS REPORT, PERITONITIS WAS RESOLVING, AND ANTIBIOTIC TREATMENT WITH AN UNSPECIFIED ANTIBIOTIC WAS ONGOING. THE PATIENT WAS STILL IN THE HOSPITAL AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136381 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R DIANEAL, KEPPRA, DEPAKOTE