BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4232701 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39146
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 11, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS REPORT INVOLVES A PATIENT WHO EXPERIENCED CLOUDY EFFLUENT IN THE CONTEXT OF PERITONEAL DIALYSIS. WHILE THERE WAS NO PERITONITIS REPORTED, IT IS CURRENTLY UNABLE TO BE RULED OUT AS A CAUSE FOR THE REPORTED SYMPTOMS. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. 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. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. TREATMENT, CAUSE, AND OUTCOME WERE NOT REPORTED. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712757 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TITANIUM ADAPTER, MINICAP, DIANEAL