BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC: 400ML, 2-14ML/HR SAF + 5 ML/30MIN

    MDR report key: 3960107 · Received June 23, 2014

    Report

    Report Number
    2026095-2014-00100
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED TO BE RETURNING FOR AN ANALYSIS, BUT HAS NOT YET BEEN RECEIVED. THE REVIEW OF THE DEVICE HISTORY RECORDS (DHR) IS CURRENTLY IN PROGRESS FOR THE LOT NUMBER PROVIDED. RESULTS: AT THIS TIME THE RESULTS ARE PENDING THE COMPLETION OF THE INVESTIGATION WHICH IS CURRENTLY IN PROCESS. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FIELD ONCE THE INVESTIGATION HAS BEEN COMPLETED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    FILL VOLUME: 550 ML. FLOW RATE: UNK. PROCEDURE: UNK. CATHPLACE: NOT APPLICABLE. PLEASE REFERENCE: 2026095-2014-00098/(B)(4), 2026095-2014-00099/(B)(4), IT WAS REPORTED THAT THERE WERE 3 INCIDENTS OF STUCK BOLUS BUTTON REPORTED. INCIDENT 3 OF 3: ON (B)(6) 2014, SHORTLY AFTER THE PT WAS CONNECTED TO THE PUMP (MODEL B006, LOT NO. 0200991709), THE PHYSICIAN OR NURSE ATTEMPTED TO PUSH THE BOLUS BUTTON AND THE BUTTON WAS STUCK. IT WAS UNK HOW LONG THE BUTTON REMAINED STUCK, BEFORE THE PUMP WAS DISCONTINUED. LOCATION OF THE ORANGE INDICATOR WAS REPORTED TO BE POSITIONED AT THE BOTTOM. AT THIS TIME, THE BUTTON IS NO LONGER STUCK. IT IS UNK IF THE RED TAB WAS PULLED; HOWEVER THE SAMPLE CURRENTLY DOES NOT HAVE THE RED TAB IN IT. SPECIFIC PATIENT INFO WAS UNK; HOWEVER N ADVERSE EVENT OCCURRED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364779 ON-Q C-BLOC: 400ML, 2-14ML/HR SAF + 5 ML/30MIN ELASTOMERIC PUMP MEB I-FLOW LLC CB006 02000991709

    Patients

    Seq Age Sex Outcome Treatment
    1 *ANP*