BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3873127 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18966
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13I04032 AND H13F07023 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. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE HOSPITALIZATION, THE PATIENT BEGAN TREATMENT WITH KEFZOL AND FORTAZ (DOSES, FREQUENCIES AND ROUTES UNKNOWN) FOR PERITONITIS. THE TREATMENT WAS DISCONTINUED AFTER FOURTEEN DAYS. ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DIANEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS FULLY RECOVERED FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350010 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DIANEAL PD4 1.5% AND 2.5% ULTRABAG| CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD),| CASSETTE, MINICAP, EXTENSION SET