BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4241965 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39804
    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

    COMPLAINT NO: CMPLNT-(B)(4). (B)(6). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 14G020 WAS MANUFACTURED JULY 10, 2014 TO JULY 11, 2014. THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION ON THE DEVICE (VIA THE NAKED EYE) NOTED A SOLID WHITE FRAGMENT OF THE DUCKBILL VALVE COMPONENT APPROXIMATELY 2.40 MM IN SIZE, FLOATING IN THE FLUID PATHWAY OF THE RESERVOIR. THE PARTICLE WAS IDENTIFIED TO BE POLYISOPRENE MATERIAL VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) SCANNING. THE REPORTED CONDITION WAS VERIFIED, THOUGH NO CAUSE COULD NOT BE DETERMINE WITH THE PROVIDED INFORMATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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 HAD A PLASTIC PARTICLE IN AN UNSPECIFIED LOCATION. THE REPORTER PROVIDED AMOUNTS OF DRUGS USED (3G/10MG HC IN 52ML) HOWEVER, THE DRUGS WERE NOT SPECIFIED. THIS WAS NOTICED AFTER FILLING AND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723302 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14G020

    Patients

    Seq Age Sex Outcome Treatment
    1