BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4233275 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39185
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM JUNE 05, 2014 ¿ JUNE 06, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION A BLACK PARTICLE MEASURING APPROXIMATELY 0.07 MM IN SIZE WAS OBSERVED ON THE FILTER OF THE DEVICE. THERE WAS AN INSUFFICIENT AMOUNT OF THE PARTICLE TO PERFORM FOURIER TRANSFORM INFRARED SPECTROSCOPY. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE PARTICLE IS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (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 LARGE VOLUME INTERMATE HAD A BLACK MARK ON ITS FILTER. THIS WAS FOUND BEFORE USE. THE DEVICE WAS FILLED WITH AN UNKNOWN ANTIBIOTIC. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713694 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14F003

    Patients

    Seq Age Sex Outcome Treatment
    1