BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3083260 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10697
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING MANUAL PERITONEAL DIALYSIS THERAPY. 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. 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

    THIS IS A REPORT OF PERITONITIS CAUSED BY A BREACH IN ASEPTIC TECHNIQUE. THE PATIENT WAS TRYING TO REMOVE FIBRIN FROM THEIR PERITONEAL DIALYSIS LINE (UNSPECIFIED) WITH TWEEZERS. ON AN UNSPECIFIED DATE IN (B)(6) 2012, THE PATIENT BEGAN CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD. THE PATIENT PRESENTED WITH CLOUDY FLUID, ABDOMINAL PAIN, DIARRHEA AND VOMITING. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH GENTAMICIN AND CEFTAZIDIME. THE PATIENT WAS DISCHARGED WITH 3 WEEKS OF ORAL CIPROFLOXACIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185151 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R EXTRANEAL 1.5%| DIANEAL 1.36%| DIANEAL 2.27%