FDA alerts to Class I recall of Sapphire Infusion Pumps due to software issues, failure to detect air in the line

According to the FDA, Eitan Medical Ltd’s September 11, 2023 recall of its Sapphire Infusion Pumps, running on software version Rev 16.10, has been upgraded to Class I because use of the product could result in major injuries or death.

Consumers should note that the ongoing recall is not a product removal but a voluntary, nationwide correction that covers 1,383 devices across three different models:

Operated on battery power and when connected a power source, the Sapphire infusion pumps are designed for use in clinical, home, and transitional settings. They facilitate the delivery of fluids, nutrition (including lipids), medication, blood, and blood products (like platelets and plasma).

The company took action back in September after identifying software issues in software version Rev 16.10, which is run in Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump. When running on battery power, pumps with this particular software version were shown to be at risk of failure to detect air in the line. Officials also noted some cases in which no alarm was sounded when air was present in the line.

Patients who are subjected to undetected air in the line could experience a blockage in a blood vessel (also known as an embolism), which could ultimately lead to other adverse health outcomes like “unstable blood pressure, stroke, heart attack, or even death.”

While Eitan Medical Ltd has not received any reports of injury or death in connection to the problem, those who use the affected Sapphire infusion pumps and healthcare providers who use and/or recommend the pumps to their patients are asked to be advised of the recall.

A letter addressed to Directors of Nursing, Pharmacy, Biomedical Engineering, and Risk Management sent on September 11 and 12, 2023, instructed readers to

  • Cease use of all recalled Sapphire Infusion Pumps run on battery power
  • Ensure that devices are connected to a power supply or continuous AC power
  • Affix an “air-eliminating” filter onto the device

Since the recall, Eitan Medical Ltd has been able to identify the issue within software version Rev 16.10, which is no longer offered. The company anticipates that a new and corrective software update will be available in four months to date of the FDA communication.

Further questions and concerns about the recall can be directed to the company’s customer service team at 1-877-541-9944, or via email at customerservice@eitanmedical.com. Adverse events or complaints can be reported at complaints@eitanmedical.com.

As the FDA continues to oversee the recall, healthcare professionals and consumers are encouraged to report related adverse experiences to the agency’s MedWatch program.


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