BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUROS PORT PROTECTOR

    MDR report key: 2163586 · Received July 11, 2011

    Report

    Report Number
    MW5021327
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    May 15, 2011
    Report Date
    July 11, 2011
    Manufacturer
    IVERA MEDICAL CORPORATION
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BETWEEN (B)(6) 2011, WE HAD (4) PATIENTS IDENTIFIED AS HAVING CANDIDA INFECTIONS AND ALL PATIENTS HAD LINES PLACED DURING THEIR ADMISSIONS. THE TYPES OF CANDIDA VARIED AMONGST PATIENTS AND INVOLVED CANDIDA ALBICANS, GLABRATA AND PARAPSILOSIS. PRIOR TO THIS TIME, LINE INFECTIONS HAVE BEEN RARE AT OUR FACILITY. WE HAVE DONE AN EXTENSIVE REVIEW TO LOCATE THE SOURCE OF THESE INFECTIONS BUT HAVE BEEN UNABLE TO CONFIRM THE SOURCE. AS A PART OF OUR REVIEW, IT WAS IDENTIFIED THAT USE OF THE CUROS PORT PROTECTOR CAPS ON OUR LINES WERE THE ONLY RECENT CHANGE. WE FIRST PUT THE CAPS INTO USE AS A TRIAL IN OUR ICU ON (B)(6) 2011. SINCE THAT TIME, WE HAVE BEGUN TO USE THEM ACROSS THE HOUSE. ALTHOUGH WE HAVE NOT IDENTIFIED THE CAPS AS A CAUSE OF THE INFECTION, IT WAS RECOMMENDED THAT WE REPORT AS A PRECAUTION. WE WERE TOLD BY THE MANUFACTURER THAT THEY HAVE NOT BEEN INFORMED OF ANY SIMILAR TYPES OF ISSUES WITH THIS PRODUCT. PER THE MANUFACTURER, THEY DO NOT HAVE TESTING AT THIS TIME THAT SHOWS THE EFFICACY OF THE CUROS PORT PROTECTOR IN REGARDS TO CANDIDA (AS IT IS NOT REQUIRED). DATES OF USE: IMPLEMENTED (B)(6) 2011 PULLED (B)(6) 2011. REASON FOR USE: CENTRAL LINE. ALSO SEE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUROS PORT PROTECTOR CUROS PORT PROTECTOR LKB IVERA MEDICAL CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention