BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANFER SET

    MDR report key: 3802611 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14942
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). DATE OF EVENT: THE PATIENT EXPERIENCED PERITONITIS ON AN UNREPORTED DATE IN (B)(6) 2014. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) H13E31025 AND H13H20055 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. 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 HOSPITALIZED ON AN UNREPORTED DATE IN THE SAME MONTH AS THE ONSET OF THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS (DOSE, ROUTE, AND FREQUENCY UNKNOWN). ON AN UNREPORTED DATE IN THE SAME MONTH AS THE HOSPITALIZATION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281428 MINICAP TRANFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE, DIANEAL 2.5% LOW CALCIUM, MINICAP