BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3803118 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15053
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE AND LOT NUMBER OF THIS PRODUCT ARE UNKNOWN; HOWEVER, THE BRAND NAME AND 510K NUMBER OF THE POTENTIAL PRODUCT CODES AND LOTS RECEIVED BY THE CLINIC ARE THE SAME; THEREFORE THEY WERE PROVIDED. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFTAZIDIME (DOSE AND FREQUENCY NOT REPORTED) AND (IP) VANCOMYCIN EVERY 5 DAYS FOR 21 DAYS (DOSE NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281349 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, MINICAP| DIANEAL PD4 LOW CALCIUM SOLUTION