BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 8374246 · Received February 27, 2019

    Report

    Report Number
    1416980-2019-01112
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    February 4, 2019
    Report Date
    February 27, 2019
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    UDI-DI
    00085412488103
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT WAS MANUFACTURED JULY 3 - 7, 2018. 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 INTERMATE RUPTURED. THIS OCCURRED DURING FILLING WITH 2GR OF CEFTRIAXONE IV AND 100ML OF 0.9% SODIUM CHLORIDE SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168553 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE NA 18G001 00085412488103

    Patients

    Seq Age Sex Outcome Treatment
    1