BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B/F WARM SET W/48" EXT CE

    MDR report key: 3825330 · Received May 21, 2014

    Report

    Report Number
    0001831750-2014-03006
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    KZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS UNABLE TO BE EVALUATED BY A STRYKER REPRESENTATIVE AS IT WAS DISPOSED OF BY THE CUSTOMER. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FACILITY NOTICED SHAVINGS AROUND THE FEMALE PORT OF THE BLOOD FLUID WARMER CASSETTE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER FACILITY NOTICED SHAVINGS AROUND THE FEMALE PORT OF THE BLOOD FLUID WARMER CASSETTE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301582 B/F WARM SET W/48" EXT CE DEVICE, WARMING. BLOOD AND PLASMA KZL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1