BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3903288 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20947
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED MARCH 4, 2014 ¿ MARCH 6, 2014. EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED WHITE PARTICLES 0.15 TO .30 MM IN SIZE FLOATING INSIDE THE RESERVOIR. THE PARTICLES WERE IDENTIFIED TO BE AN ACRYLIC MATERIAL VIA FOURIER TRANSFORM INFRARED (FT-IR) SPECTROPHOTOMETER SCANNING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. A CAPA WAS OPENED TO INVESTIGATE THE ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD PARTICULATE MATTER IN ITS RESERVOIR. THIS WAS NOTICED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380707 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14C014

    Patients

    Seq Age Sex Outcome Treatment
    1