BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3083252 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10695
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H12L08013 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THERAPY WAS ONGOING. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT INFORMATION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. THIS IS REPORT 4 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183804 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other HOMECHOICE, DIANEAL AMBUFLEX AND DIANEAL ULTRABAG