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U.S. Department of Health and Human Services

Class 1 Device Recall BD Alaris System PC Unit Model 8100 (Pump Module)

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  Class 1 Device Recall BD Alaris System PC Unit Model 8100 (Pump Module) see related information
Date Initiated by Firm August 04, 2020
Create Date September 12, 2020
Recall Status1 Open3, Classified
Recall Number Z-2939-2020
Recall Event ID 85962
510(K)Number K133532  
Product Classification Pump, infusion - Product Code FRN
Product BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer Reason
for Recall		 Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
FDA Determined
Cause 2		 Device Design
Action On August 4, 2020, the firm notified affected customers via mail, "Urgent Medical Device Recall", indicating the following: Actions for Clinical Users: Clinicians should remove the pump from service and send to Biomedical Engineering if the Pump Module keypad becomes unresponsive or stuck. If a critical medication is being administered, continue the infusion until it is safe to replace the Pump Module. In an urgent situation, clinicians can close the roller clamp on the IV administration set to stop an infusion. Actions for Cleaning Personnel: Follow the cleaning instructions provided in the current Directions for Use to minimize the potential for fluid ingress during cleaning. - Do not use a cloth that drips. Be sure to wring out the cleaning cloth to squeeze out excess fluid. - Do not spray fluids directly onto the device. Actions for Biomedical Engineering: Inspect all uninstalled Pump Module Door Assembly Replacement Kits noted above. All kits dated prior to January 25, 2019 are affected. If affected kits are found upon inspection, dispose per facility guidelines. An example of how to identify the date on the keypad is provided below: - Contact BD at 1-800-482-4822 to order replacement Pump Module keypad kits at no charge (either discarded by your facility or needed for remediation of the Pump Module), - Contact the BD Recall Support Center at 1-888-562-6018 to schedule remediation of the pump module at no charge if unable to perform at your location. - Maintain a list of all Pump Module serial numbers remediated to provide to BD upon completion of the activity. Please promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and the recall instructions provided in this letter. Actions for BD Alaris System rental providers: Provide a copy of this letter to your customers who are currently renting BD Alaris System devices. Actions by BD: BD redesigned and implemented the Alaris Pump Mo
Quantity in Commerce 248,519
Distribution Worldwide: US* (AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY); United Arab Emirates (AE); Australia (AU); Canada (CA); Hungary (HU); Israel (IL); Japan (JP)* Kuwait (KW); New Zealand (NZ); Philippines (PH); Qatar (QA); Saudi Arabia (SA); Singapore (SG); Taiwan (TW); Turkey (TR)*. *There are 159 U.S. government and/or military consignees including two located in Japan (JP) and Turkey (TR).
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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