FDA-Device2021-04-07Class I
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
CareFusion 303, Inc.
Hazard
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
Sold states
Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ
Affected count
160300
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1309-2021Don't want to check this manually?
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