Fill volume: 500ml.Flow rate: 10ml/hr.Procedure: robotic colectomy.Cathplace: tap.Please reference: 2026095-2015-00003/(b)(4).Pump #2 of 2.A pt reported experiencing worsening of symptoms from local anesthetic while using 2 pumps.The pt experienced several episode of chills, blurred vision, increased heart rate (hr), and anxiety while in the hosp.The infusion began at that time with unspecified pumps.The symptoms were intermittent (not constant) while hospitalized.The pt stated that different devices were used at facility to infuse anesthetic.On (b)(6) 2014, the on-q pumps were placed prior to discharge.Upon discharge, the side effects became constant and worsened.The pt was treated with an unspecified anti-anxiety medication; however, the symptoms did not resolve after taking the medication.It was reported that the pt experienced the symptoms for 3 days at various times.The pt was instructed to clamp the pumps and notify the surgeon.The pt followed up with the physician who instructed the pt to remove the pumps.The infusion ended at that time on (b)(6) 2014.Upon removal, the pumps were not empty and contained most of the medication.Within the hr, the symptoms subsided.The device was saved for return.
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Method: the device was reported to be returning for an eval and at this time is pending return.A review of the device history record (dhr) is in progress for the reported lot number.Results: at this time, (b)(4) is pending the receipt of the device and as the investigation is still in progress, results are not available.Once the device is received, testing will be performed and results will be provided upon completion.Conclusions: once the investigation and device analysis are completed, a f/u report will be submitted.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for add'l investigations.
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