BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-VUE 6

    MDR report key: 5234063 · Received November 18, 2015

    Report

    Report Number
    3004437723-2015-00001
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2015
    Manufacturer
    TEMPTIME CORPORATION
    Product Code
    LJT
    PMA / PMN Number
    BK910005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE OF THE FOUR INDICATORS THAT FAILED TO REACH ENDPOINT AS EXPECTED WAS RETURNED TO TEMPTIME AND EXAMINED; HOWEVER, IT HAD SINCE REACHED ENDPOINT AND ITS APPEARANCE WAS TYPICAL FOR A SAFE-T-VUE 6 INDICATOR THAT HAD ALREADY REACHED ENDPOINT. SAMPLES FROM THE SAME BOX AS THE AFFECTED INDICATORS, AS WELL AS RETENTION SAMPLES FROM THE SAME LOT OF INDICATORS WERE TESTED AND FOUND TO FUNCTION AS SPECIFIED.

    Description of Event or Problem · 1

    SAFE-T-VUE 6 IS A TEMPERATURE SENSITIVE INDICATOR THAT ADHERES DIRECTLY ONTO BLOOD BAGS AND PROVIDES A VISUAL INDICATION WHEN THE BLOOD PRODUCT HAS REACHED OR EXCEEDED THE SPECIFIED TEMPERATURE OF 6°C. THE INCIDENT OCCURRED WHEN FOUR (4) SAFE-T-VUE 6 INDICATORS FAILED TO REACH ENDPOINT AT 6°C ±0.3°C DURING A VALIDATION STUDY. ALTHOUGH THIS FAILURE OCCURRED DURING A VALIDATION AND HAD NO PATIENT IMPACT, IT COULD POTENTIALLY AFFECT PUBLIC HEALTH IF IT RECURRED AND THE SAFE-T-VUE 6 INDICATOR FAILED TO SHOW A TEMPERATURE EXCURSION ABOVE 6°C ON BLOOD THAT WAS USED FOR TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762665 SAFE-T-VUE 6 IRREVERSIBLE TEMPERATURE INDICATOR LJT TEMPTIME CORPORATION 7206 S6011315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other