Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.

Complaints where users were unable to prime the administration set.

A "Medical Device Safety Notification" Letter dated April 20, 2018 was to all affected customers, stating that the firm has become aware of issues with infusion pump administration sets. Customers are experiencing difficultly or failing to prime the pump administrative sets. Infusion pump administration sets, various models with check valves manufactured during January 2017 through March 2018. Issue: The Infusion pump administration sets require priming prior to patient use as described in the directions for use. It is during the priming process that this issue can be observed. During priming, when attempting to fill the drip chamber, the drops into the drip chamber will not be observed once the roller clamp is opened. This issue is highly detectable. Steps for detecting this issue during priming: -Open administrative set package, remove set and close roller clamp. -Insert administrative set spike into the IV bag or bottle and hang container 20 inches above the Pump module. -Fill drip chamber to 2/3 full. -Open the roller clamp. -Drips into the drip chamber will be very slow or absent. Potential Risk: An occlusion in the administration set line can prevent the ability to prime the set, rendering the administration set unusable. The inability to prime can contribute to the delay of the start of the infusion. There have been no reports of patient harm as a result of this issue. Recommended Steps for Users: You can continue to use the product as this issue is highly detectable. If during priming you experience a difficultly or inability to prime, please notify CareFusion Customer Advocacy at 888-812-3266 or [email protected]. Meantime, BD has the following options if you experience this issue: In some instances clinicians may be able to increase the pressure to assist the check valve by gently squeezing the IV bag following these steps: 1. Begin by removing the IV set from the package and close the roller clamp. 2. Spike the bag of IV flu