BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3873377 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-19020
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM MARCH 4, 2014 TO MARCH 6, 2014. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED WHITE PARTICLES, BETWEEN 0.20 AND 0.50 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) SCANNING FOUND THE PARTICLES TO BE ACRYLIC MATERIAL. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE CAUSE WAS UNABLE TO BE DETERMINED. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. 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 PARTICULATE MATTER IN THE ELASTOMERIC BLADDER. THIS WAS IDENTIFIED WHILE THE DEVICE WAS BEING FILLED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349095 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14C014

    Patients

    Seq Age Sex Outcome Treatment
    1