BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEL 1 FLUID WARMING DEVICE

    MDR report key: 3818195 · Received May 8, 2014

    Report

    Report Number
    2183502-2014-00281
    Event Type
    Death
    Date Received
    May 8, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM THE (B)(6) STATING THAT THEY WERE CONDUCTING AN INVESTIGATION OF A PATIENT DEATH. ACCORDING TO THE REPORTER, A PATIENT EXPIRED DURING USE OF AN UNIDENTIFIED FLUID WARMING DEVICE. THE REPORTER STATED THAT THE EVENT OCCURRED IN A NICU SETTING. NO INDICATION HAS BEEN MADE THAT ANY FAULT OF THE DEVICE OCCURRED. FURTHER INFO HAS BEEN REQUESTED. NO FURTHER INFO HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279577 LEVEL 1 FLUID WARMING DEVICE WARMER, THERMAL, INFUSION FLUID LGZ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death