BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3841249 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17438
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL CRAMPS, VOMITING, CHILLS, AND CLOUDY EFFLUENT BAG COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ONE DAY AFTER THE ONSET OF PERITONITIS; THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (FREQUENCY, DURATION, AND ROUTE NOT REPORTED) FOR THE PERITONITIS. PERITONITIS TREATMENT WITH THE UNSPECIFIED ANTIBIOTICS CONTINUED FOR FIVE DAYS. THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS EVENT. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319151 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention DIANEAL 2.5% AND 4.25% PD4, AND EXTRANEAL 7.5%| HOMECHOICE