BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3113806 · Received May 15, 2013

    Report

    Report Number
    1416980-2013-12391
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 22, 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). THE AGE IN THIS EVENT IS UNKNOWN. THE NURSE INDICATED THAT THE PATIENT WAS BORN IN 1935. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT'S TREATMENT WAS STARTED WITH ALPHACEF (3GRAM9G0/DAY) AND MEDFURIN (2G/DAY) (ROUTES NOT REPORTED) FOR PERITONITIS. THIRTEEN DAYS LATER, ANTIBIOTIC TREATMENT WAS STOPPED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215950 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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