BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3100267 · Received May 8, 2013

    Report

    Report Number
    1416980-2013-11714
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION CONTAINING APPROXIMATELY 240ML OF SOLUTION IN THE RESERVOIR. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF FLOW AT THE DISTAL LUER. THE CAUSE WAS DETERMINED TO BE EXCESS SOLVENT AT THE BONDING JUNCTION OF THE TUBING AND THE DISTAL LUER POST. AWARENESS TRAINING WAS CONDUCTED FOR ALL APPLICABLE MANUFACTURING OPERATORS; SUBSEQUENT TO THE MANUFACTURE OF THIS DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE WAS NOT FLOWING PROPERLY. THIS WAS IDENTIFIED DURING INFUSION. THERE WAS A PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200782 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12J055

    Patients

    Seq Age Sex Outcome Treatment
    1