BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3478613 · Received November 20, 2013

    Report

    Report Number
    1416980-2013-32063
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    October 16, 2013
    Report Date
    October 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER 13B016 WAS MANUFACTURED BETWEEN FEBRUARY 6, 2013 - FEBRUARY 8, 2013. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. 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 AN OVER INFUSION OF 100 ML OF 0.2% ROPIVACAINE HYDROCHLORIDE HYDRATE AND 0.4 ML OF MORPHINE (NON-BAXTER PRODUCTS) WAS OBSERVED IN AN INFUSOR. THE TOTAL FILL VOLUME WAS 100.4 ML, AND ONLY ABOUT 80 ML WAS LEFT INSIDE THE PUMP AFTER 2 HOURS OF INFUSION. THE EXPECTED FLOW RATE WAS 100 ML/48 HRS. THE CUSTOMER STATED THAT A PATIENT CONTROL MODULE (PCM) WAS CONNECTED, BUT THE MEDICATION DEMAND BUTTON WAS NOT PRESSED DURING INFUSION. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603362 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13B016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 100 ML OF 0.2% ROPIVACAINE HYDROCHLORIDE HYDRATE| 0.4 ML OF MORPHINE