Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Recall
- Recall Number
- Z-1811-2015
- Event Number
- 71081
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 13, 2015
- Posted
- June 16, 2015
- Terminated
- May 20, 2016
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
CareFusion sent an Urgent Medical Device Recall Notification letter dated May 13, 2015 to customers. The letter identified the affected product, problem and the recommended actions to be taken. Customers are informed that CareFusion has released a software upgrade to address this issue. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the software upgrade installation. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PT, [email protected]. Customers with adverse event report questions are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days a week, [email protected]. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PT, Mon-Fri, [email protected].
US Nationwide Distribution
63 units