BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3211263 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17730
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE WAS RETURNED FOR EVALUATION. THE COMPANION SAMPLE WAS VISUALLY INSPECTED FOR ANY SIGNS OF ABNORMALITY THAT COULD CONTRIBUTE TO THE REPORTED CONDITION; HOWEVER, NONE WERE FOUND. A FUNCTIONAL FLOW RATE TEST WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE OF THE PRODUCT. THE REPORTED CONDITION WAS NOT CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE HAD AN UNDERINFUSION OF A NON-BAXTER DRUG, WHERE THE INFUSION LASTED SIX HOURS INSTEAD OF THE EXPECTED THREE HOURS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NOT PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311292 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11M027

    Patients

    Seq Age Sex Outcome Treatment
    1 PROFENID DRUG