BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP

    MDR report key: 12729678 · Received November 1, 2021

    Report

    Report Number
    1416980-2021-06527
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 5, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412477275
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H4: DEVICE MANUFACTURE DATE: JUNE 25, 2019 - JUNE 26, 2019. H10: THREE DEVICE WAS RECEIVED FOR EVALUATION. UNAIDED VISUAL INSPECTION WAS PERFORMED AND OBSERVED A DEFECT AT THE ¿H¿ IN BAXTER HEALTHCARE SA FIXED PRINT IN FRONT OF BAG. ADDITIONAL MAGNIFIED INSPECTION WAS PERFORMED WHICH OBSERVED A SMALL HOLE WHERE THE LEAK AND PRINT DEFECT WERE VERIFIED. FUNCTIONAL TESTING WAS PERFORMED WHICH REVEALED A LEAK AT THE AFFECTED AREA. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THE MOST LIKELY CAUSE WAS DUE TO MANUFACTURING PROCESS. 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

    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 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING. THIS WAS FURTHER DESCRIBED AS ¿ONCE THE TECHNICIAN STARTED FILLING FROM THE BULK BAG INTO THE SMALLER IV (INTRAVENOUS) BAGS, THEY NOTICED THAT THE 5000ML EVA BAG WAS LEAKING IN THE AREA WHERE BAXTER HEALTHCARE NAME AND ADDRESS IS STAMPED ON THE BAG.¿ THIS WAS IDENTIFIED DURING FILLING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629231 EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60192945 00085412477275

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown