BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10342414 · Received July 30, 2020

    Report

    Report Number
    1416980-2019-07946
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081373
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM. THIS REPORT WAS INITIALLY REPORTED TO THE FDA THROUGH VMSR REPORT # 1416980-2020-00293. (B)(6). LOT 19C034 WAS MANUFACTURED FROM MARCH 22-25, 2019. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED FLUID INSIDE THE BAG THAT CONTAINED THE DEVICE. WHEN THE DEVICE WAS REMOVED FROM THE BAG, THE CAUSE OF THE FLUID WAS FOUND TO BE AN UNTIGHTENED BLUE WINGED LUER CAP. A FUNCTIONAL LEAK TEST WAS PERFORMED BY FILLING THE DEVICE WITH WATER AND MANUALLY TIGHTENING THE BLUE WINGED LUER CAP. DURING AND AFTER FILL, NO SIGNS OF A LEAK WERE OBSERVED FROM THE DEVICE. THE REPORTED CONDITION WAS NOT VERIFIED. THE DEVICE WAS FOUND TO BE CONFORMING PRODUCT. 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.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED LARGE VOLUME INFUSOR, THE DEVICE WAS FOUND TO BE LEAKING FROM THE BLUE WINGED LUER CAP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809785 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19C034 00085412081373

    Patients

    Seq Age Sex Outcome Treatment
    1