Alaris Pump, Model 8100, with bezel mechanical assemblies… recallZ-1768-2019 · CareFusion 303, Inc. · initiated Apr 13, 2018

Why it was recalled

The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.

FDA root cause category: Component design/selection

What the company is doing

On 04/20/18, the firm mailed Medical Device Recall Notification letters. Customers were advised that affected units outlined in the previous September 1, 2017 recall will now include affected devices with date codes September 2011 through December 2011. Customers were asked to remove the pump from use if there are signs of infusion at an unexpected rate. Use non-affected devices in high risk areas if possible. Consider having additional devices as back up until your affected devices are remediated. If the user experiences the issue described in this notification, clearly mark and sequester the devices from use and notify Support Center. Customers were asked to complete and return the Customer Response Cards to acknowledge receipt of the notification. Firm will contact all affected customers within 60 days to replace the mechanical assemblies on affected serial numbers at no charge. Customers experiencing the issue described in this notification are encouraged to call the Support Center at 888-562-6018 or email [email protected]. On 04/15/19 the firm mailed URGENT: Medical Device Recall Notification letters. Customers were advised that the firm will contact customers of Priority 1 pumps within 60 days of this notification to initiate scheduling of the inspection of those pumps. The firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Until the bezels affected by this recall are replaced by the firm, customers should inspect bezels of both Priority 1 and Priority 2 pumps during their annual preventative maintenance schedule. Any pumps with bezel post separation should be removed from service. The recalling firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Customers were asked to complete and return Customer Response Cards to acknowledge receipt of this notification. In addition to the Support Cente

Recall details

Recall number

Z-1768-2019

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Apr 13, 2018

Posted by the FDA

Jul 16, 2019

Recalling firm

CareFusion 303, Inc.

Quantity

607618

Product code

FRN

FDA submissions

K133532

Distribution

Worldwide Distribution - U.S. Nationwide CA, TX, NC, AL, ID, TN, IN, MA, UT, HI, NH, PA, IL, OR, FL, MI, VA, AR, OH, GA, NY, MD, MN, NM, AZ, KY, WI, NE, MS, DC, MO, KS, SC, LA, MT, WA, NJ, CO, CT, OK, AK, AS, CU, DE, GU, IA, ME, MP, ND, NV, PR, SD, VT, WV, WY; OUS: AE, AU, BH, CA, CH, CN, GI, IL, IN, KW, MX, MY, NL, NZ, PH, PK, QA, SA, SG, TW, and ZA.

Product description

Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204). Product Usage: The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural. There are 6 bezel posts on the Alaris Pump bezel assembly.

Other devices under the same FDA submission

4 devices cleared under K133532 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Alaris™ Pump Module, Model 8100

  Carefusion 303, Inc. · Pump, infusion
  1 recall2 deaths5,636 reports
• Alaris 8975

  Carefusion 303, Inc. · Infusion safety management software
  169 reports
• Alaris 9601

  Carefusion 303, Inc. · Pump, infusion
  1 recall0 reports
• Alaris™ Syringe Module, Model 8110 8100

  Carefusion 303, Inc. · Pump, infusion
  14 reports