BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4252471 · Received November 15, 2014

    Report

    Report Number
    1416980-2014-40800
    Event Type
    Malfunction
    Date Received
    November 15, 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 AUGUST 4, 2014 - AUGUST 5, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A WHITE PARTICLE 1.55MM IN LENGTH, FLOATING IN THE SOLUTION OF THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY REVEALED THAT THE PARTICLE WAS MADE OF ACRYLIC. THE CAUSE OF THE CONDITION WAS NOT 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

    (B)(4). THE DEVICE WAS RECEIVED FOR ANALYSIS AND AN EVALUATION HAS BEGUN BUT HAS NOT YET BEEN COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE WAS OBSERVED TO HAVE PARTICULATE MATTER IN THE BLADDER. THE UNIT CONTAINED CASPOFUNGIN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740611 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14H002

    Patients

    Seq Age Sex Outcome Treatment
    1 CASPOFUNGIN