BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3853896 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18184
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 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). SAMPLE WAS RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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).THE LOT 14B047 WAS MANUFACTURED BETWEEN FEBRUARY 27, 2014 AND MARCH 4, 2014. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE VISUAL INSPECTION (VIA THE NAKED EYE) NOTED PARTICULATES RANGING BETWEEN 1.50 TO 5.50 MM IN SIZE, FLOATING INSIDE THE FLUID OF THE RESERVOIR. THE PARTICLES WERE IDENTIFIED TO BE ACRYLIC MATERIAL VIA FTIR SPECTROPHOTOMETER SCANNING. BASED ON THE EVALUATION FINDING, THE PRODUCT DID NOT MEET PRODUCT SPECIFICATION AND WAS THEREFORE A NONCONFORMING PRODUCT. THE CAUSE OF THE REPORTED CONDITION WAS UNABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION. 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. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332780 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B047

    Patients

    Seq Age Sex Outcome Treatment
    1