BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4093430 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31526
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 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 HAS BEEN RECEIVED AND EVALUATION IS UNDERWAY. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE LOT WAS MANUFACTURED ON JUNE 6, 2014 ¿ JUNE 11, 2014. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. VISUAL INSPECTION OF THE UNIT REVEALED A SOLID WHITE PARTICLE 1.59 MM IN LENGTH FLOATING IN THE FLUID OF THE BLADDER. SPECTROPHOTOMETER SCANNING WAS PERFORMED AND THE PARTICLE WAS IDENTIFIED AS AN ACRYLIC MATERIAL. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD PARTICULATE MATTER INSIDE THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571302 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14F004

    Patients

    Seq Age Sex Outcome Treatment
    1