BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1000 ML TPN BAG

    MDR report key: 10871220 · Received November 19, 2020

    Report

    Report Number
    1416980-2020-07249
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 1, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D10, H3 AND H6. CORRECTION TO G1: MANUFACTURER'S INFORMATION. G1: THE CORRECT MANUFACTURER'S INFORMATION IS AVAILMED C. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND. TIJUANA, BAJA CALIFORNIA 22444, MEXICO OR BAXTER HEALTHCARE ¿ ENGLEWOOD 14445 GRASSLANDS DR ENGLEWOOD, CO. 80112 UNITED STATES, PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE CORPORATION. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION THE SPIKE PORT WAS RECEIVED WITH THE COVER REMOVED AND THE SPIKE PORT MEMBRANE WAS NOT BROKEN THROUGH TO SECURELY ATTACH A SPIKE MEMBRANE. THE TEST SPIKE EASILY FELL OUT OF THE SPIKE PORT. HOWEVER, THE SPIKE WAS CORRECTLY. CORRECTLY SPIKED MEMBRANE AND SAMPLE FUNCTIONED AS IT WAS INTENDED UPON PROPER SPIKING. FUNCTIONAL LEAK TESTING WAS PERFORMED, AND NO LEAK WAS OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 1000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS DEFECTIVE. THE DEFECT WAS FURTHER DESCRIBED AS "THE IV TUBING CAME OUT OF THE BAG" AND RESULTED IN A FLUID LEAK. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332833 1000 ML TPN BAG SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED AMINO ACID FLUID