BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4093981 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31620
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). THIS REPORT INVOLVES AN UNKNOWN BAXTER TRANSFER SET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE EVENT (PREVIOUSLY RECOVERING). NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT BEGAN TREATMENT WITH INJECTIONS OF FORTUM (1 GRAM, FREQUENCY AND ROUTE NOT REPORTED), INJECTIONS OF REFLIN (1 GRAM, FREQUENCY AND ROUTE NOT REPORTED) AND INJECTIONS OF HEPARIN (1000 UNIT EACH BAGS 3 DAYS, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571602 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention TITANIUM ADAPTER, MINICAP, 2.5% DIANEAL PD2