BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 7131169 · Received December 19, 2017

    Report

    Report Number
    1416980-2017-09890
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED 27 JUN 2017 - 29 JUN 2017. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADDER OF A SMALL VOLUME INFUSOR RUPTURED. THE EVENT OCCURRED PRIOR TO PATIENT USE. THE DEVICE HAD BEEN FILLED WITH AN UNSPECIFIED AMOUNT OF FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911292 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 17F058

    Patients

    Seq Age Sex Outcome Treatment
    1