BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3955474 · Received July 24, 2014

    Report

    Report Number
    1416980-2014-24075
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 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). IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM APRIL 8, 2014 TO APRIL 10, 2014. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE NOTED A SOLID, WHITE PARTICLE, 0.40 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) SCANNING IDENTIFIED THE PARTICLE TO BE ACRYLIC MATERIAL. THE CAUSE OR ORIGIN OF THE PARTICLE WAS UNABLE TO 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBSERVING PARTICULATE MATTER INSIDE THE RESERVOIR OF AN INTERMATE ELASTOMERIC DEVICE. THIS WAS OBSERVED OUTSIDE OF PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433483 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14D012

    Patients

    Seq Age Sex Outcome Treatment
    1