BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 11770308 · Received May 4, 2021

    Report

    Report Number
    1937141-2021-00002
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Report Date
    June 3, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    20812496011514
    PMA / PMN Number
    K960581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G2: REPORT SOURCE WAS CORRECTED TO INDICATE A FOREIGN ENTITY AND HEALTH PROFESSIONAL. H6: INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS WERE UPDATED BASED ON THE RESULTS OF THE ATTACHED DEVICE EVALUATION AND SUBSEQUENT INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHARMACY TECHNICIAN THAT WHILE FILLING A SECURE EVA DUAL CHAMBER 3000 ML BAG, LOT 66631-A6597, A SMALL AMOUNT OF LIPIDS IN THE UPPER CHAMBER PREMATURELY MIGRATED INTO THE ADMIXTURE OF SOLUTIONS IN THE LOWER CHAMBER. THERE WAS NO PATIENT INVOLVEMENT. THE UNIT WAS RETURNED TO METRIX FOR EVALUATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670774 SECURE 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET KPE THE METRIX COMPANY 66631 66631-A6597 20812496011514

    Patients

    Seq Age Sex Outcome Treatment
    1