Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
This recall is currently active, issued October 20, 2023. It was issued by Eitan Medical Ltd 29, Yad Kharutsim Netanya Israel.
- Recall Initiated
- September 11, 2023
- Posted
- October 20, 2023
- Recall Number
- Z-0094-2024
- Quantity
- 1383
- Official Source
- View on FDA website ↗
Reason for Recall
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Distribution
US nationwide distribution.
Lot / Code Info
Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161
Root Cause
Software Design Change
Action Taken
On 9/11/23, recall notices were emailed to customers informing them of the following: The Affected Pumps may fail to identify air in line when the following conditions are met: 1. The pump is operating on battery power (not connected to a power supply) 2. Treatments are water-like solutions (TPN and other opaque solutions are not affected) Until the Affected Pumps in your facility have been updated with new software, users are advised to only operate the effected devices as follows: i. Connect to continuous AC power during treatment (i.e., connect to a power supply) and/or; ii. Use with air eliminating filters sets: - Available Eitan Medical sets with filters: AP206-01, AP240-01, AP 214-01, AP 204-01, AP223-01, or; - Connect a 3rd party air eliminating filter set extension to the end of the Sapphire set. Alternatively, use software version - Rev15.10. Complete and return the Customer Response form via email to compliance@eitanmedical.com To report adverse events or product complaints, contact Global Complaint Management, complaints@eitanmedical.com If additional information or technical assistance, contact Customer Service and Technical Assistance, customerservice@eitanmedical.com 1-877-541-9944