BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4112225 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32936
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS ON AN UNREPORTED DATE IN (B)(6) 2014. 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 PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT TO POSSIBLY BE DUE TO UNSPECIFIED WATER BORNE INFECTION BUT THIS COULD NOT BE MEDICALLY CONFIRMED. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS INTRAPERITONEALLY (DOSE AND FREQUENCY NOT REPORTED) AND CIPRO (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE EVENT. THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE EVENT. IT WAS REPORTED THAT PD CATHETER WAS REMOVED AND THERAPY WAS SWITCHED TO HEMODIALYSIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592461 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE, CASSETTE, MINI-CAP| DIANEAL 2.5% AND 4.25%