The FDA has announced several infusion pump recalls by the manufacturers recently. These are Class 1 recalls which present the highest level of threat of serious injury and/or death at risk. The following companies have issued the recalls:
- Eitan Medical Ltd Sapphire Infusion Pumps
- Becton Dickinson (BD)/CareFusion Alaris Infusion Pumps
In addition, Baxter International Inc. issued an urgent medical device correction on the Novum IQ.
The Voluntary Recall of Eitan Medical Ltd. Sapphire Infusion Pumps
The voluntary recall issued by Eitan Medical affects their Sapphire Infusion Pumps running their software version Rev 16.10 was initiated on September 11, 2023, and includes the following models:
- Multi-Therapy (Ref 15031-000-0028)
- Epidural (Ref 15032-000-0027)
- SapphirePlus (Ref 15038-000-0001)
These pumps are being recalled because the software that they use has an issue that may cause it to fail to detect air in the line. Air in the lane has poses a risk of injecting air bubbles into the patient’s vein which may result in an air embolism. An air embolism can result in a blockage of the artery/vein and may have serious consequences. If it blocks passage to the brain, loss of consciousness or seizure may result whereas if it blocks passage to the heart, heart attack or arrhythmia may result. The failure may occur when the device is operated on battery power vs being plugged in. Patients using this product are NOT to discontinue use, but to ONLY use the device on continuous AC power (plugged in) and only with air-eliminating filters. For more information, visit the Eitan Medical Recall page. No injuries have been reported to date.
The Becton Dickinson (BD)/CareFusion Alaris Infusion Pump Recall
The voluntary recall issued by Becton Dickinson (BD)/CareFusion affects the Alaris infusion pump and includes the following models:
- BD Alaris Syringe Module
- BD Alaris PCU
- Alaris PCA Module
These pumps are being recalled because of compatibility issues with Cardinal Health Monoject syringes. Apparently, due to a dimension change of the company’s syringes, the pump may either refuse to operate or incorrectly estimate the volume of liquid in the syringe. This may result in the patient receiving over or under-infusion. This has the potential to cause serious injury or death. Visit the Becton Dickenson (BD)/CareFusion Alaris Recall page. At present, there have already been 13 reports of injury as a result of this defect.
The Baxter International, Inc Novum IQ Urgent Medical Device Correction
The device in question in the Baxter urgent medical device correction is the Novum IQ syringe infusion pump with product code 40800BAXUS. Baxter International has NOT actually recalled their devices. Instead, they have identified problems where their device may display an “Infusion Complete” alarm when there is still medication in the syringe and the infusion is not actually complete. Baxter is notifying their customers of the issue and is developing a software solution to fix the problem. In the meantime, they are instructing users to take certain precautions and monitor the volume to be infused for accuracy.
Talk to a Defective Infusion Pump Lawyer
If you or a loved one have suffered a serious injury or death due to the use of one of the above devices, talk to a defective infusion pump lawyer to determine your options today. Simmons and Fletcher, P.C., stands ready to help victims of serious injuries and accidents seek compensation for their injuries as the personal injury and product liability law firm has for over four decades. Call 800-298-0111 to discuss your options today.
Warning: Do not stop taking using a prescribed medical device entirely without first consulting a physician.
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