BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2233656 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22549
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADDITIONAL INFORMATION: THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. A LABELING REVIEW FOUND THE DIRECTIONS FOR USE: MIXING AND USE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED VIA PHONE THAT AN INFUSOR UNDERINFUSED DURING PATIENT USE. A VOLUME OF APPROXIMATELY 100 ML WAS INFUSED OVER THE COURSE OF 48 HOURS RATHER THAN 24 HOURS. THIS IMPLIES A 2.1 ML/HR FLOWRATE, WHICH IS 42% OF THE EXPECTED FLOWRATE. THE DEVICE WAS FILLED WITH A PRE-COMPOUNDED SOLUTION OF 0.1% ROPIVACAINE IN SALINE MANUFACTURED BY PHARMEDIUM. INFUSION FLOW RATE LESS THAN 70% OF EXPECTED RATE COULD LEAD TO A SERIOUS INJURY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11F018

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR ROPIVACAINE