BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3953725 · Received July 23, 2014

    Report

    Report Number
    1416980-2014-23936
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE LOT 14E046 WAS MANUFACTURED MAY 19, 2014 TO MAY 20, 2014. THE ACTUAL DEVICE WAS EVALUATED. VISUAL INSPECTION (VIA THE NAKED EYE) NOTED A SOLID PARTICLE 1.6 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER. THE PARTICLE WAS IN THE FLUID PATH. THE PARTICLE WAS IDENTIFIED TO BE POLYETHYLENE MATERIAL VIA FT-IR SPECTROPHOTOMETER SCANNING. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A LARGE VOLUME INFUSOR WAS FOUND PARTICULATE MATTER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431096 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14E046

    Patients

    Seq Age Sex Outcome Treatment
    1