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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris System with Guardrails Suite MX

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  Class 1 Device Recall Alaris System with Guardrails Suite MX see related information
Date Initiated by Firm April 13, 2018
Create Date July 16, 2019
Recall Status1 Open3, Classified
Recall Number Z-1768-2019
Recall Event ID 82143
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product 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.
Code Information All pumps manufactured between April 2011 and June 2017, that have bezel mechanical assemblies manufactured with FR-110 plastic resin. And all pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.         
Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer Reason
for Recall
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 Determined
Cause 2
Component design/selection
Action 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 888-562-6018 or email SupportCenter@carefusion.com 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. Customers were asked to complete and return Customer Response Cards to acknowledge receipt of this notification.
Quantity in Commerce 603730
Distribution Worldwide Distribution - U.S. Nationwide AK, AL, AR, AS, AZ, CA, CO, CT, CU, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = CAREFUSION 303, INC.
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