BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4111127 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32814
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, 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 THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN, THE PATIENT FEELING FULL, AND CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE PATIENT'S SKIN CELLS SHEDDING INTO THE PERITONEUM MIGHT HAVE CAUSE PERITONITIS BUT THIS WAS NOT MEDICALLY CONFIRMED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH ANTIBIOTIC DERIVATIVES OF PENICILLIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR THE EVENT. IN ADDITION, THE PATIENT WAS GIVEN BENADRYL, BEFORE GIVING ANY OTHER ANTIBIOTICS FOR PERITONITIS. THE PATIENT HAD NOT RECOVERED FROM THE EVENT AT THE TIME OF THE REPORT. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592575 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5% APD AND DIANEAL 2.5% APD| HOMECHOICE| TRANSFER SET, CASSETTE, AND MINI-CAP