BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4241988 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39802
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 15, 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). THE DEVICE HAD BEEN FILLED WITH 2.5G / 10MG HYDROCORTISONE IN 42ML. THE DEVICE WAS MANUFACTURED JUNE 5, 2014 TO JUNE 6, 2014. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A SOLID WHITE FRAGMENT APPROXIMATELY 2.09 MM IN SIZE, FLOATING IN THE FLUID OF THE RESERVOIR. FOURIER TRANSFORM INFRARED SPECTROSCOPY REVEALED THAT THE PARTICLE WAS MADE OF POLYISOPRENE. THE PARTICLE WAS DETERMINED TO BE A FRAGMENT OF THE DUCKBILL VALVE COMPONENT. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. 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 HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SINGLE DAY INFUSOR HAD A PLASTIC PARTICLE IN AN UNSPECIFIED LOCATION. THE REPORTER PROVIDED AMOUNTS OF DRUGS USED (2.5G 10MG HC IN 42ML) HOWEVER THE DRUGS WERE NOT SPECIFIED. THIS WAS NOTICED AFTER FILLING AND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721738 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F005

    Patients

    Seq Age Sex Outcome Treatment
    1