BD—Model 8100 Alaris Pump Modules and Air-in-Line Sensor Kits: May Exhibit False Air-in-Line Alarm
December 7, 2016 | Risk Management News
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In a December 2, 2016, Medical Device Safety Notification letter submitted by an ECRI Institute member hospital, BD states that while the above pumps are infusing, the system may indicate that an AIL alarm has occurred when no air is in the line. In some cases, these false AIL alarms may be attributed to a faulty AIL sensor. BD also states that during an infusion, a false AIL alarm would cause the infusion to be interrupted, necessitating that the operator clear the alarm. If the AIL sensor is faulty, the alarm may recur. Interruption of infusion could lead to injury requiring medical intervention. BD further states that false AIL alarms because of faulty AIL sensors could also occur during service or maintenance operations. In these cases, there would be a delay in putting the device into service.
Action Needed:Identify any affected product in your inventory. If you have affected product, verify that you have received the December 2, 2016, Medical Device Safety Notification letter, tip sheet, and Customer Response Card from BD. If an AIL alarm occurs,...