BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL BLOOD/FLUID WARMER

    MDR report key: 3132514 · Received May 29, 2013

    Report

    Report Number
    0001831750-2013-04837
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    November 30, 2012
    Report Date
    May 1, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    KZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT BLOOD WAS FOUND INSIDE THE UNIT UPON BEING RETURNED FOR SERVICE. THIS FAILURE MODE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY/DEATH AS THE FLUID WARMER IS UNDER POSITIVE PRESSURE TO PREVENT CROSS CONTAMINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS POTENTIAL BIO-CONTAMINATION HAZARD DUE TO BLOOD FOUND INSIDE OF THE BLOOD/FLUID WARMER UNIT. 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 VIA REPAIR WORK ORDER THAT THERE WAS POTENTIAL BIO-CONTAMINATION HAZARD DUE TO BLOOD FOUND INSIDE OF THE BLOOD/FLUID WARMER UNIT. 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
    237507 CAPITAL BLOOD/FLUID WARMER DEVICE, WARMING. BLOOD AND PLASMA KZL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1