BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD/FLUID WARMER

    MDR report key: 2530296 · Received March 30, 2012

    Report

    Report Number
    1313850-2012-00092
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLUID WARMING UNIT WAS TESTED AND FOUND TO BE OPERATING TO SPECIFICATION, WITH NO SHARP EDGES FOUND WITHIN THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLUID CASSETTE RUPTURED IN THE WARMER. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1