BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4111272 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32842
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN JUNE 10, 2014 AND JUNE 12, 2014. EVALUATION SUMMARY: VISUAL INSPECTION NOTED A SOLID WHITE FRAGMENT APPROXIMATELY 2.24 MM IN SIZE, FLOATING IN THE FLUID OF THE RESERVOIR. THE PARTICULATE MATTER WAS IDENTIFIED TO BE A FRAGMENT OF DUCK-BILL VALVE, AND WAS IDENTIFIED TO BE POLYISOPRENE VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY SCANNING. THE CAUSE COULD NOT BE DETERMINED. A CAPA HAS BEEN INITIATED TO INVESTIGATE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HALF DAY INFUSOR WAS OBSERVED WITH PARTICULATE MATTER OBSERVED IN ITS RESERVOIR. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS IDENTIFIED BEFORE PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590227 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F023

    Patients

    Seq Age Sex Outcome Treatment
    1