BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3833682 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17078
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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 LOT WAS MANUFACTURED FROM MARCH 4, 2014 TO MARCH 6, 2014. THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND IDENTIFIED WHITE PARTICLES, BETWEEN 0.02 TO 4.50 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) SCANNING IDENTIFIED THE PARTICLES TO BE ACRYLIC MATERIAL. THE CAUSE AND ORIGIN OF THE PARTICLES COULD NOT BE DETERMINED. 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. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER INSIDE THE BALLOON OF A SMALL VOLUME INTERMATE. THIS WAS NOTED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310026 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14C014

    Patients

    Seq Age Sex Outcome Treatment
    1