BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20D V/NV NTG .2MF 1SS DEHP FREE

    MDR report key: 10423083 · Received August 18, 2020

    Report

    Report Number
    9616066-2020-02527
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 14, 2020
    Report Date
    July 28, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203015806
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED ISSUE HAS DETERMINED THIS INCIDENT HAS ALREADY BEEN CAPTURED UNDER MANUFACTURER REPORT NUMBER 9616066-2020-02434 OR PR# (B)(4). THE PRODUCT DEFECTS AND INCIDENT WHICH OCCURRED AND REPORTED UNDER THIS COMPLAINT HAVE ALREADY BEEN PROVIDED, THEREFORE THIS COMPLAINT CAN BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20D V/NV NTG .2MF 1SS DEHP FREE EXPERIENCED AIR IN LINE ALARM DURING USE AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INFUSION WAS STARTED AT 1255 AND THE NURSE OPENED THE CHAMBER BECAUSE THE PUMP WAS SAYING AIR IN LINE AT 1312. THE PATIENT WAS NOT INJURED DURING THE EPISODE . THE NURSE DID HAVE MEDICATION SPRAYED ON HER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20D V/NV NTG .2MF 1SS DEHP FREE EXPERIENCED AIR IN LINE ALARM DURING USE AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INFUSION WAS STARTED AT 1255 AND THE NURSE OPENED THE CHAMBER BECAUSE THE PUMP WAS SAYING AIR IN LINE AT 1312. THE PATIENT WAS NOT INJURED DURING THE EPISODE . THE NURSE DID HAVE MEDICATION SPRAYED ON HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885729 GEM 20D V/NV NTG .2MF 1SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20016288 07613203015806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 8100,8015, 20200714.