BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4220009 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38374
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 8, 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 ADAPTOR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: UPON FOLLOW UP, IT WAS REPORTED THAT THE INFECTION WAS NOT PERITONITIS. THE REPORTED PRODUCT IS NO LONGER CONSIDERED SUSPECT IN THIS EVENT. 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 A SUSPECTED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS REPORTED THAT THE PATIENT¿S EFFLUENT WAS FILLED WITH PUS. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN INDICATION PRIOR TO THE EVENT. TREATMENT AND OUTCOME OF THE EVENT WAS NOT REPORTED. ON THE SAME DAY AS HOSPITALIZATION, PD THERAPY WAS DISCONTINUED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704003 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other EXTRANEAL, MINICAP| DIANEAL 1.5%, HOMECHOICE, CASSETTE, TRANSFER SET