Zyno Medical Z-800 (infusion pumps)

2024: Recall of the device due to a defect due to which air enters the blood and a stroke occurs

In mid-October 2024, Zyno Medical announced that it was withdrawing Z-800, Z-800F, Z-800W and Z-800WF infusion pumps from sale due to a software defect that could lead to a stroke due to the formation of air embols.

The Z800 series infusion systems are designed for intravenous administration of nutrients, various drugs and blood preparations under the supervision of a health care professional. The company recalls these pumps due to a defect in the software algorithm that monitors the ingress of air into the system. Due to a software error, 1.0 ml air bubbles can enter the infusion pump, which can seriously harm the patient, including leading to embolism of the cerebral arteries and stroke. Among potential adverse events, rapid and irregular heartbeat, myocardial infarction, seizures and even death are also highlighted. Zyno reported two cases of injuries in connection with this problem, but no deaths have yet been reported.

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Intuvie.com

On September 13, Zyno sent a letter to all affected customers about the need to urgently adjust the software of infusion systems, in which it recommended to stop using all devices subject to withdrawal. As soon as it is determined that the product is subject to withdrawal, a representative of Intuie, a partner company of Zyno, will contact customers to agree on instructions for replacing the device. Paramedics are also advised to send out this notice to anyone who needs this information but has not been able to obtain it directly from the company. Healthcare professionals and patients can also inform the manufacturer and regulatory authorities of any adverse reactions that have occurred with these devices through the MedWatch program.^[1]

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