BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3802273 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14896
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH INJ VANCOMYCIN (2 GRAMS PER 5 DAY), INJ FORTUM (1 GRAM PER DAY), AMIKACIN (100 MG PER DAY; ROUTE NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, THE PT'S CATHETER WAS REMOVED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280660 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention DIANEAL PD4 1.5% AND 2.5% ULTRABAG