BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1000 ML TPN BAG

    MDR report key: 10975995 · Received December 9, 2020

    Report

    Report Number
    1416980-2020-07654
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Report Date
    January 6, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412477237
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO E1: INITIAL REPORTER CITY: (B)(6) . CORRECTION MADE TO G5: PMA/510K #: K900585 (PREVIOUSLY SUBMITTED AS KN90085). H4: THE LOT WAS MANUFACTURED FROM NOVEMBER 20, 2019 - NOVEMBER 21, 2019. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 1000 ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS DETECTED AT THE STATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444361 1000 ML TPN BAG SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60215802 00085412477237

    Patients

    Seq Age Sex Outcome Treatment
    1