BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2883560 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07928
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION AND THE REPORTED CONDITION WAS CONFIRMED DURING PRODUCT EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED, WHICH FOUND THAT THE CONTROL MODULE COULD BE TURNED WITHOUT THE KEY. HOWEVER, THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A BAXTER SALES REPRESENTATIVE (BSR) NOTIFIED BAXTER CORPORATE PRODUCT SURVEILLANCE (CPS) OF AN INFUSOR, WHICH A NURSE HAD REPORTED, WHERE THE RATES WERE ABLE TO BE CHANGED WITHOUT A KEY. THIS OCCURED DURING A TRAINING AND WAS USED WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12G025

    Patients

    Seq Age Sex Outcome Treatment
    1