Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication

Recalled Product

• Alaris Pump Model 8100 Infusion Sets
• Lot Numbers: See full list of affected devices in BD recall notice
• Manufacturing Dates: May 1, 2016 to March 31, 2019
• Distribution Dates: July 1, 2016 to April 18, 2019
• Devices Recalled in the U.S.: 151,139,816
• Date Initiated by Firm: May 6, 2019

Device Use

Becton Dickinson (BD) Alaris Infusion Sets are used with an infusion pump to deliver fluids including medications, blood, or blood products, into a patient's body in a controlled manner. The pump administers fluid via an infusion tubing set into a patient's vein or through other cleared routes of administration. 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 of different lengths. These infusion sets are intended to be used with the BD Alaris Pump Module 8100. The devices are used in hospitals and other health care facilities.

Reason for Recall

Becton Dickinson (BD) is recalling Alaris Infusion Sets, due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a "running status." The firm has determined that the silicone segment of the affected administration set has non-uniform thickness. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing. This device defect may cause serious adverse health consequences for patients, including death. This recall has been associated with MDR reports, several of which are associated with serious injuries.

Who May be Affected

• Hospitals and health care professionals using Alaris Infusion Sets, which include silicone segments to be used with the BD Alaris Pump Module 8100.
• Patients of all ages who may receive fluids, medications, blood, or blood products delivered by a BD Alaris Pump Module 8100 through the Alaris Administration Sets affected by this recall.  

What to Do

On May 6, 2019, BD sent customers an Urgent Medical Device Recall informing them of the device models and lot numbers of the Alaris Infusion Sets affected by this recall. On July18, 2019, the Urgent Medical Device Recall was amended, with the following instructions:

• Immediately review your inventory for the specific model codes and lot numbers listed in the Affected Product Table. Destroy all product subject to the recall following your institution's process for destruction.
• Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall.
• Report any case of over-infusion or other serious or unexpected medical device incidents to BD. When reporting, please identify the model code and lot number to aid in the investigation process.
• Complete the attached Customer Response Form and return to the BD contact noted on the form whether you have any of the impacted material or not, so that BD may acknowledge your receipt of this notification and provide product replacement.
• Report any adverse reactions or events experienced with the use of this product to the FDA's MedWatch Program by:
  • Web: MedWatch website at www.fda.gov/medwatch
  • Phone: 1-800-FDA-1088 Fax: 1-800-FDA-0178
  • Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787