BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3142077 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14036
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 9, 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.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS WITH CLOUDY EFFLUENT. THE HP WAS TREATED WITH CEFEPIME (IP) AND ORAL LEVAQUIN. THE HP WAS DISCHARGED AND WAS REPORTED TO BE RECOVERING. THE HP HAD A RECURRENT CASE OF PERITONITIS AND WAS HOSPITALIZED AGAIN AND TREATED WITH THE SAME ANTIBIOTICS. THE HP WAS DISCHARGED FROM THE HOSPITAL AND ON AN UNREPORTED DATE WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. THE HP WAS REPORTED TO BE RECOVERING. BAXTER HEALTHCARE OBTAINED ADDITIONAL INFORMATION FROM THE NURSE, WHO STATED THE HP HAD A BREAK IN ASEPTIC TECHNIQUE (FURTHER DETAILS NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244059 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R DIANEAL AND HOMECHOICE