BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3873363 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-19008
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    March 4, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 13D005 WAS MANUFACTURED BETWEEN MARCH 31, 2013 AND APRIL 2, 2013. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE AFFECTED DEVICE WAS RECEIVED AT THE PLANT FOR EVALUATION. INITIAL VISUAL INSPECTION OF THE UNIT NOTED A RUPTURED RESERVOIR. MICROSCOPIC EVALUATION FOUND MARKINGS LOCATED ON THE EXTERIOR SURFACE OF THE RESERVOIR NEAR THE RUPTURE LINE. NO CAUSE COULD BE DETERMINED AS TO THE ORIGIN OF THE MARKINGS OR THE RUPTURED RESERVOIR. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION IS IN PROGRESS, UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE RUPTURED. THE RUPTURE OCCURRED DURING FILLING WITH 50ML OF AN ANTIBIOTIC DRUG (NON BAXTER). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349332 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13D005

    Patients

    Seq Age Sex Outcome Treatment
    1 FORTUM