BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4091587 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31429
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERITONITIS EVENT IN (B)(6) 2013. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. TREATMENT AND OUTCOME OF THE PERITONITIS EVENT WAS NOT REPORTED. APD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570944 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HOMECHOICE, TITANIUM ADAPTER, MINICAP, CASSETTE.| DIANEAL