BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 9873289 · Received March 24, 2020

    Report

    Report Number
    1416980-2020-01671
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    February 28, 2020
    Report Date
    April 20, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412081366
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS ADDED: PMA/510K # CORRECTION: K071222 (PREVIOUSLY NA). THE LOT WAS MANUFACTURED FROM JANUARY 2, 2019 - JANUARY 3, 2019. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED USING AND FOUND FLUID INSIDE THE BAG THAT CONTAINED THE SAMPLE. FUNCTIONAL TESTING WAS PERFORMED BY FILLING THE DEVICE WITH GREEN COLORED WATER. AFTER FILL, THE BLUE WINGED LUER CAP WAS HAND TIGHTENED. THE SAMPLE WAS MONITORED UNTIL THE NEXT DAY AND NO SIGNS OF LEAK WERE OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED. 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

    (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 LARGE VOLUME INFUSOR WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS IDENTIFIED AT THE HOSPITAL PRIOR TO PATIENT USE. THE DEVICE WAS FILLED WITH 0.9% SODIUM CHLORIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335032 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19A001 00085412081366

    Patients

    Seq Age Sex Outcome Treatment
    1