Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
- Company
- Carefusion 303, Inc.
- Recall Initiated
- June 30, 2020
- Posted
- August 19, 2020
- Recall Number
- Z-2824-2020
- Quantity
- 89497
- Firm Location
- San Diego, CA
Reason for Recall
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, SC, NY, CA, NC, TX, IL, PA, AZ, LA, IN, MA, MO, AR, WI, HI, OR, OH, NJ, TN, NE, WA, KS, MI, MD, WV, KY, UT, MN, IA, GA, AL, DE, AK, VA, OK, NM, CT, SD, NV, ID, MT, ME, VT, MS, WY, NH, MP, DC, ND, GU, PR, AS, RI and the countries of TR, QA, CA, AE, KW, MX, GI, IL, SA, CH, NL, BE, TW, ZA, PH, CN, AU, IN, FR, MY, NZ, GB, KR, PK, DE, SG, JP, CU, IT, BH.
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
On 06/30/2020, Urgent Medical Device Recall Notifications will be mailed to Directors of Biomedical Engineering, Nursing, Risk Management, Environmental Services. Actions for Clinical User: 1. If the end user observes a dim segment on the module, replace the module when feasible. There is no impact to the infusion. 2. Complete and return the Customer Response Card. Actions by Biomedical Engineering: If the module has a dim segment, please contactrecalling firm at 1-800-482-4822 to order a replacement display board (P/N TC10012952 for LVP Display Board, P/N TC10003525 for Syringe/PCA Display Board, P/N TC10008126 for EtCO2 Display Board, P/N TC10005026 for SpO2 Display Board) at no charge or send the module to the firm's Service Depot for repair. Actions by Recalling Firm: If the module has a dim segment as described in this notification, a replacement part will be provided at no charge. On 12/16/22, Medical Device Notifications were sent to customers informing them that they may have received impacted parts for repair purposes or (b) received product with impacted parts. Customers were provided with links to the original recall notices and asked to review the information and complete the customer response form.