BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3012739 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06676
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS THE TRANSFER SET HAD DISCONNECTED DURING USE. TREATMENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115696 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization DIANEAL 2.5%, HOME CHOICE AND UNKNOWN ADAPTOR