BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10304646 · Received July 21, 2020

    Report

    Report Number
    1416980-2019-07702
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    October 18, 2019
    Report Date
    July 21, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 # 1416980-2020-00095. THE DEVICE WAS MANUFACTURED BETWEEN 07MAY2019 AND 08MAY2019. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, FLUID WAS OBSERVED INSIDE THE BAG THAT CONTAINED THE UNIT. WHEN THE UNIT WAS REMOVED FROM THE BAG, THE CAUSE OF FLUID INSIDE THE BAG WAS VISUALLY IDENTIFIED TO BE UNTIGHTENED BLUE WINGED LUER CAP. FUNCTIONAL TESTING WAS PERFORMED, THE BLUE WINGED LUER CAP WAS HAND TIGHTENED BY MANUALLY ROTATING THE CAP UNTIL THE CAP COULD NO LONGER BE ROTATED. THE UNIT WAS FILLED WITH WATER TO A NOMINAL VOLUME AND MONITORED UNTIL THE NEXT DAY. NO SIGNS OF LEAK WERE OBSERVED AT THE BLUE WINGED LUER CAP. 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. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SMALL VOLUME INFUSOR LEAKED DURING FILLING. THE LEAK WAS OBSERVED BETWEEN THE LUER ADAPTOR AND 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
    765606 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 19E015

    Patients

    Seq Age Sex Outcome Treatment
    1