BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4251240 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40604
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 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). THE DEVICE WAS MANUFACTURED 07/21/2014 - 07/23/2014. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED A WHITE PARTICLE BETWEEN 0.86 TO 1.49 MM IN LENGTH, FLOATING IN THE FLUID OF THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY IDENTIFIED THE PARTICLE TO BE ACRYLIC MATERIAL. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). 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 AN UNSPECIFIED PARTICULATE IN THE BLADDER. THIS WAS FOUND BEFORE USE. THE DEVICE WAS FILLED WITH CEFTAZIDIME AND TOBRAMYCIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT ONE OF FOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738375 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14G030

    Patients

    Seq Age Sex Outcome Treatment
    1