BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3960095 · Received June 23, 2014

    Report

    Report Number
    2026095-2014-00098
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 1, 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: AS NO DEVICE WAS AVAILABLE FOR AN EVALUATION METHODS WERE NOT PERFORMED; AND RESULTS CANNOT BE OBTAINED. CONCLUSION: THE DEVICE WAS NOT RETURNED TO I-FLOW FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. BASED ON THE LIMITED INFO THAT HAS BEEN PROVIDED BY THE REPORTER WE ARE UNABLE TO DETERMINE THE POSITION OF THE ORANGE INDICATOR. IF ADDITIONAL INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. PER THE TECHNICAL BULLETIN "ON-Q PUMPS WITH ONDEMAND BOLUS" A WARNING IS PROVIDED: IF THE BUTTON DOES NOT POP BACK UP WITHIN 30 MINUTES, CHECK POSITION OF THE ORANGE INDICATOR ON THE SIDE OF THE BOLUS DEVICE AND FOLLOW THESE INSTRUCTIONS "ORANGE REFILL INDICATOR REMAINS IN THE LOWER MOST POSITION: THE BUTTON MAY BE STUCK WHICH COULD RESULT IN MAXIMUM DOSE DELIVERY (BASAL + BOLUS) TO THE PT. ORANGE REFILL INDICATOR REMAINS IN THE UPPERMOST POSITION: FLOW MAYBE IMPEDED DUE TO AN OCCLUSION. PT IS NOT RECEIVING INFUSION. 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: 2026095-2014-00099/(B)(4)). 2026095-2014-00100/(B)(4)). IT WAS REPORTED THAT THERE WERE 3 INCIDENTS OF A STUCK ON-DEMAND BOLUS BUTTON ON THE DEVICE. INCIDENT 1 OF 3: ON AN UNK DAY IN (B)(6) 2014, THE BOLUS BUTTON BECAME STUCK. LOCATION OF THE ORANGE INDICATOR WAS UNK. THE PT WAS SENT HOME WITH THE PUMP. FURTHER DETAILS REGARDING THE EVENT WERE UNK. IT WAS UNK IF THE RED TAB WAS PULLED FROM THE UNIT. SPECIFIC PATIENT INFO WAS UNK; HOWEVER NO ADVERSE EVENT OCCURRED AS A RESULT OF THE INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364608 ON-Q C-BLOCK: 400ML, 2-14ML/HR SAF + ML/30MIN ELASTOMERIC PUMP MEB I-FLOW, LLC CB006 0200991709

    Patients

    Seq Age Sex Outcome Treatment
    1 *ANP* DRUG: ROPIVACAINE 0.2%