BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD/FLUID WARMER

    MDR report key: 2515835 · Received March 29, 2012

    Report

    Report Number
    1313850-2012-00089
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS STILL ONGOING; WHEN ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV CLAMP WAS BROKEN ON THE BLOOD FLUID WARMER. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD/FLUID WARMER BLOOD/FLUID WARMER LGZ STRYKER CORP DBA GAYMAR FW600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1