BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3132450 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13474
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS, WHICH MANIFESTED AS ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH ALFACEF 3G/DAY AND MEDFURIN 2G/DAY (ROUTES NOT REPORTED) FOR THE PERITONITIS. TWO WEEKS LATER, REMEDIAL THERAPY WAS STOPPED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT HAD RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237196 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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