Approximately 20 min after the start of the operation, the pump is raced and tubing 284504 was quickly filled with an overpressure on the side of the patient.They cut off the pump.Then changed the tubing 284504.Pb returned.So they changed the column and thus pump fms.Pb is occurring again.They even changed tubing and intervention ended normally.Finally, loss of time and short relief and a priori no consequence for the patient, but difficult to see in a knee versus a shoulder.No error code.Loss of time, increasing the operating time.Pressure, but short, so a priori inconsequential, especially in a knee.Extension of the operation 45 minutes.The patient is well.See associated medwatch 1221934-2014-00492, 1221934-2014-00493.
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The complaint tubing is not being returned and therefore is not available for a physical evaluation.However, a few unused samples of this tube set from different lots were tested to replicate this failure of fill chamber filling up and a manufacturing error was identified.Supplier identified tool wear on 3 out of 8 molds which created flash leading to increased torque needed to close the luer lock.If the luer lock is not completely tightened, an air leak occurs causing the fill chamber to overfill.The tooling was fixed by the supplier under corrective action.A pra was conducted and determined the patient risk to be low.It was noted that this lot was released before the corrective actions were implemented.A review into the depuy mitek complaints system revealed 3 similar and 1 dissimilar complaints for this lot of devices that were released to distribution.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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