BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10332777 · Received July 28, 2020

    Report

    Report Number
    1416980-2019-07875
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    October 21, 2019
    Report Date
    July 28, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    UDI-DI
    00085412022529
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM. THIS REPORT WAS INITIALLY REPORTED TO THE FDA THROUGH VMSR REPORT # 1416980-2020-00128. THE DEVICE WAS MANUFACTURED BETWEEN 12OCT2018 AND 16OCT2018. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. 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

    IT WAS REPORTED A LARGE VOLUME INFUSOR LEAKED ¿LUER CONNECTOR AFTER 5 HOURS STORAGE¿. THE DEVICE WAS FILLED WITH 5FU FOR A TOTAL VOLUME OF 233ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798084 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 18K001 00085412022529

    Patients

    Seq Age Sex Outcome Treatment
    1