BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS CLEAR PRESSURE INFUSOR

    MDR report key: 10731098 · Received October 23, 2020

    Report

    Report Number
    3004050971-2020-00010
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 28, 2020
    Report Date
    September 28, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    KZD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VITAL SIGNS CLEAR PRESSURE INFUSOR HAS TUBING LEAKS AT STOPCOCK. BUT UNKNOWN WHICH OF THE TWO LOT NUMBERS (180989 AND 180990) HAS THE LEAK. THE ISSUE OCCURRED DURING PATIENT-USE AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190481 VITAL SIGNS CLEAR PRESSURE INFUSOR INFUSOR, PRESSURE, FOR I.V. BAGS KZD VYAIRE MEDICAL VITAL SIGNS® CLEAR PRESSURE INFUSOR 180990, 180989

    Patients

    Seq Age Sex Outcome Treatment
    1