BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3853051 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18109
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT RELATED TO THIS REPORTED CONDITION. THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNDER-INFUSION THAT OCCURRED DURING THE USE OF AN INFUSOR ELASTOMERIC DEVICE. THIS OCCURRED DURING PATIENT USE, THOUGH NO PATIENT INJURY OR MEDICAL INTERVENTION WAS IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER STATED THAT AFTER THE PRESCRIBED INFUSION TIME THERE WAS STILL ABOUT 25% OF THE SOLUTION LEFT IN THE RESERVOIR. THE SOLUTION BEING INFUSED IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333116 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A033

    Patients

    Seq Age Sex Outcome Treatment
    1