Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF

FDA device recall Z-0094-2024 · posted 2023-10-20 · Open, Classified

Recall details

Recalling firm

EITAN MEDICAL LTD

Reason for recall

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

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

Root cause

Software Design Change

Status

Open, Classified

Product code

FRN

Quantity affected

1383

Distribution

US nationwide distribution.

Date initiated

2023-09-11

Date posted

2023-10-20

Location

Netanya, Israel

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