BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3871195 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18842
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENTS YEAR OF BIRTH WAS REPORTED TO BE 1953. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS PRESUMED TO BE DUE TO THE PATIENT PERSPIRING PROFUSELY WHILE PERFORMING PD THERAPY, BUT WAS NOT MEDICALLY CONFIRMED. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AS ONSET OF THE PERITONITIS. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PATIENT WAS TREATED WITH CEFTAZIDIME AND CEFAZOLIN (DOSES, FREQUENCY AND ROUTES NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SIXTEEN DAYS AFTER HOSPITALIZATION AND WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. PD THERAPY WAS REPORTED TO BE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350330 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2.5%| DIANEAL PD4 1.5%