BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 12321664 · Received August 13, 2021

    Report

    Report Number
    1416980-2021-05016
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 21, 2021
    Report Date
    September 17, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412579382
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H3, H4 AND H6. H4: THE DEVICE WAS MANUFACTURED FROM DECEMBER 11, 2020 - DECEMBER 14, 2020. ADDITIONAL INFORMATION WAS ADDED TO H3, H4 AND H6. D9: CORRECTED INFORMATION, THE DEVICE WAS NOT RECEIVED FOR EVALUATION. H4: THE DEVICE WAS MANUFACTURED FROM DECEMBER 11, 2020 - DECEMBER 14, 2020. 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 NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 TWO (2) LARGE VOLUME INFUSORS HAD BACKFLOW. THIS ISSUE WAS DISCOVERED DURING USE OF THE DEVICE BY THE PHARMACIST. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215747 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 20N008 00085412579382

    Patients

    Seq Age Sex Outcome Treatment
    1