BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4093801 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31597
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 22, 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

    COMPLAINT NO: (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. (B)(6). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONEAL CLOUDY EFFLUENT AND WAS SUSPECTED TO HAVE PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. TREATMENT FOR THE EVENT WAS NOT REPORTED. THE CAUSE OF THE CLOUDY EFFLUENT AND SUSPECTED PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE OUTCOME OF THIS EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572836 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER-HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TITANIUM ADAPTER AND MINICAP| DIANEAL PD2 2.5% SOLUTION