BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4221263 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38557
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL FLOW RATE TESTING WERE PERFORMED. THE NOMINAL FLOW RATE WAS FOUND TO BE WITHIN SPECIFICATION. NO MALFUNCTIONS OR ABNORMALITIES WERE IDENTIFIED DURING PRODUCT EVALUATION. 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE UNDER INFUSED WITH A PATIENT. THE DEVICE WAS FILLED WITH PAMIDRONATE AND A TOTAL SOLUTION VOLUME OF 250 ML. THE EXPECTED INFUSION TIME WAS 2.5 HOURS; HOWEVER, AFTER 4 HOURS ONLY 80% OF THE SOLUTION VOLUME HAD INFUSED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701179 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14G025

    Patients

    Seq Age Sex Outcome Treatment
    1 PAMIDRONATE