BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    250 ML TPN BAG

    MDR report key: 8559539 · Received April 27, 2019

    Report

    Report Number
    1416980-2019-02369
    Event Type
    Malfunction
    Date Received
    April 27, 2019
    Date of Event
    March 31, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BAXTER HEALTHCARE ¿ ROUND LAKE
    Product Code
    LHI
    UDI-DI
    00085412477213
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS MANUFACTURED JULY 20, 2018 TO JULY 22, 2018. THE DEVICE WAS EVALUATED. UNAIDED VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED WHICH IDENTIFIED A SPIKE PORT CAP LEAK AT THE BASE OF THE SPIKE PORT TUBING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. THIS ISSUE IS BEING FURTHER INVESTIGATED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHT - (B)(6) KG. (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 250ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS DISCOVERED PRIOR TO PATIENT ADMINISTRATION. THERE WAS NO 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
    352126 250 ML TPN BAG SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE ¿ ROUND LAKE NA 60138236 00085412477213

    Patients

    Seq Age Sex Outcome Treatment
    1