BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3882960 · Received June 19, 2014

    Report

    Report Number
    1416980-2014-19439
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). AS THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN, AN EVALUATION COULD NOT BE PERFORMED. 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 TURBID LIQUID OR CLOUDY EFFLUENT ALONG WITH SYMPTOMS OF ABDOMINAL PAIN AND DIARRHEA. FIVE DAYS AFTER THE ONSET OF THE SYMPTOMS, THE PATIENT WAS TREATED WITH GENTAMYCINE AND BRISTOPEN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PROPHYLAXIS. THE EVENTS OF TURBID LIQUID, ABDOMINAL PAIN AND DIARRHEA WERE STILL ONGOING AND THE PATIENT HAD NOT YET RECOVERED. IT WAS UNKNOWN WHETHER THE TREATMENT WAS STILL ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359776 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention DIALYSIS CAPD 55