BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3932706 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22557
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING FOLLOW UP THAT THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY FLUID AND ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH AN UNSPECIFIED MEDICATION (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE EVENT. PATIENT OUTCOME WAS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 CLOUDY EFFLUENT ALONG WITH SYMPTOMS OF ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. CAUSE AND TREATMENT WAS NOT REPORTED. THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409796 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other