BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3834163 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17143
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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).THIS LOT WAS MANUFACTURED FEBRUARY 14, 2014 ¿ FEBRUARY 18, 2014. EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED WHITE PARTICLES BETWEEN 0.04 TO 3.50 MM IN SIZE FLOATING IN THE FLUID IN THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY FOUND THE PARTICULATE MATTER TO BE ACRYLIC MATERIAL. THE CAUSE OF THE PROBLEM 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN THE BALLOON OF A SMALL VOLUME INTERMATE. THIS WAS NOTED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310385 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B011

    Patients

    Seq Age Sex Outcome Treatment
    1