BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3180792 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16054
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 29, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H12K09112 AND H13B07048 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) HOME PATIENT (HP) EXPERIENCED FUNGAL PERITONITIS. IT WAS REPORTED, THE HP DEVELOPED A FUNGAL INFECTION (UNSPECIFIED) LATER CLARIFIED TO BE FUNGAL PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE THE PATIENT?S PD CATHETER WAS REPLACED. FIVE DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE HP WAS DISCHARGED. ON AN UNREPORTED DATE, THE HP WAS SWITCHED TO HEMODIALYSIS THERAPY. AT THE TIME OF THIS REPORT HEMODIALYSIS WAS ONGOING. AT THE TIME OF THIS REPORT, THE HP WAS RECOVERING FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280197 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization MINICAP| HOMECHOICE| DIANEAL PD4 AMBUFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD4 ULTRABAG