BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1822523 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03063
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 3, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    A BAXTER EMPLOYED HEALTHCARE PROFESSIONAL FROM (B)(6) REPORTED AN INCIDENT OF PERITONITIS. THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010, NOT REQUIRING HOSPITALIZATION. THE PATIENT DID NOT RECEIVE REMEDIAL THERAPY, AND THE OUTCOME AND ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN. DIANEAL AND EXTRANEAL THERAPIES CONTINUED. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL AND EXTRANEAL THERAPIES. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2010. THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG IN (B)(6) 2010, (DOSE AND FREQUENCY NOT REPORTED) AND EXTRANEAL VIAFLEX, (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX