BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4103313 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32453
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 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 HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PARTICULATE MATTER WAS REPORTED TO BE INSIDE OF THE RESERVOIR. THE LOT WAS MANUFACTURED FROM FEBRUARY 27, 2014 TO MARCH 4, 2014. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE IDENTIFIED A SOLID, WHITE PARTICLE, BETWEEN 0.70 AND 2.50 MM IN LENGTH, FLOATING IN THE FLUID OF THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY SCANNING IDENTIFIED THE PARTICLE TO BE ACRYLIC MATERIAL. THE CAUSE OR ORIGIN OF THE PARTICLE WAS UNABLE TO BE DETERMINED. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. 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 FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A LARGE VOLUME INTERMATE HAD PARTICULATE MATTER. THE REPORTER STATED THAT THIS WAS IDENTIFIED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584954 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B047

    Patients

    Seq Age Sex Outcome Treatment
    1