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Recall Observatory FDA recall evidence

Device product

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.

Z-1309-2021

March 03, 2021

Class I

Product summary

Firm
CareFusion 303, Inc.
Event
Event 87387
Status
Ongoing
Classification
Class I
Quantity
160300
Official record key
device-enforcement:Z-1309-2021

Official wording

Reason: 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

Code information: Pump Module with Keypad: manufactured January 23, 2019 to December 5, 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15, 2019 to November 14, 2019.

Distribution pattern: Worldwide distribution. US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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