Alaris Pump model 8100 with software version 9.1.18 and s... — Device Recall

Product Description

Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature 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 IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

Reason for Recall

CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.

Lot / Code Information

Serial no. 14031885 14031892 14031897 14031916 14032037 14032060 14032075 14032083 14032091 14032105 14032510 14032588 14032682 14032683 14032684 14032686 14032729 14032741 14032774 14032775 14035370 14035776 14035827 14035855 14035963 14036178 14036191 14036215 14036219 14036422 12773501 13184780 13932274 13932283 13932301 13932329 13932333 13990520 13990521 13990661 13990694 13990697 13990698 13990699 13990701 13990738 13990741 13990742 13990807 13990872 13990928 13990930 13990938 13990955 13990957 13990958 13990976 13990978 13990982 13990985 13990999 13991000 13991002 13991008 13991013 13991014 13991020 13991028 13991031 13991037 13991044 13991048 13991052 13991056 13991066 13991073 13991084 13991088 13991089 13991090 13991107 13991109 13991150 13991167 13991168 13991169 13991170 13991171 13991184 13991196 13991225 13991229 13991231 13991247 13991248 13991306 13991308 13991312 13991339 13991342 13991375 13991379 13991458 13991495 13991502 13991525 13991527 13991564 13991566 13991577 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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

Recall Number	Z-1567-2014
Classification	Class I — Serious risk
Date Initiated	April 23, 2014
Status	Terminated
Voluntary	Voluntary: Firm initiated

Firm	CareFusion 303, Inc.
Location	San Diego, CA
Product Type	Devices
Quantity	57,219 units total (55,756 units in US)

Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" ...

Recall Summary

Recalling Firm