BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4052224 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29277
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. 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 THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN INTRAPERITONEALLY (IGRAM STAT), INJECTION AMIKACIN (500MILLIGRAM STAT), INJECTION AMIKACIN (100MILLIGRAM OD), AND INJECTION FORTUM (1GRAM OD) FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. 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
    533125 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention DIANEAL, HOMECHOICE, TITANIUM ADAPTER, MINICAP.