Fresenius Kabi’s Ivenix Infusion System Faces FDA Recall: Patient Safety at Risk

Fresenius Kabi’s Ivenix Infusion System, a widely used medical device in healthcare settings, is facing a serious recall by the FDA. The recall has been labeled as Class I, which indicates the highest level of risk to patient safety. The reason behind the recall is a software issue that can potentially lead to severe harm or even death.

The recall specifically targets the Ivenix Infusion System LVP software, which is responsible for controlling the infusion pump. Multiple software anomalies have been identified, raising concerns over the accurate and reliable administration of fluids to patients. The affected software version is 5.8.0, and the distribution dates range from March 6, 2023, to March 20, 2024.

Fortunately, there have been no reported injuries or deaths associated with this issue. However, the potential risks are significant, highlighting the urgency of the recall. Patients who receive treatment in healthcare settings and the healthcare personnel responsible for administering blood and medications are the primary parties affected by this recall.

To address the problem, Fresenius Kabi will release a new software version for the Ivenix Large Volume Pump. This updated software aims to rectify the existing software anomalies and ensure the safe and accurate delivery of fluids to patients.

This is not the first time Fresenius Kabi has faced a recall with their Ivenix Infusion System. In a previous incident, the FDA labeled the company’s recall of the LVP-0004 model as Class I due to mechanical issues with fluid valve pins. These pins, located inside the pump’s internal housing, had the potential to impact the side of a sensor, compromising the device’s functionality.

The Ivenix Infusion System plays a crucial role in the controlled administration of fluids, medications, and blood products to both adult and pediatric patients in hospital and outpatient care environments. The safety and reliability of this device are paramount for the well-being of patients, and the FDA’s recall serves as a reminder of the importance of vigilant quality control and risk management in the healthcare industry.

FAQ – Fresenius Kabi Ivenix Infusion System FDA Recall:

1. What is the reason for the FDA recall of Fresenius Kabi’s Ivenix Infusion System?
The FDA recall of Fresenius Kabi’s Ivenix Infusion System is due to a software issue that can potentially lead to severe harm or even death.

2. Which specific part of the Ivenix Infusion System is affected by the recall?
The recall specifically targets the Ivenix Infusion System LVP software, which is responsible for controlling the infusion pump.

3. What are the identified concerns with the affected software version?
Multiple software anomalies have been identified, raising concerns over the accurate and reliable administration of fluids to patients.

4. What is the risk level associated with the recall?
The recall has been labeled as Class I, indicating the highest level of risk to patient safety.

5. Have there been any reported injuries or deaths related to the software issue?
Fortunately, there have been no reported injuries or deaths associated with the software issue.

6. Who are the primary parties affected by this recall?
Patients who receive treatment in healthcare settings and the healthcare personnel responsible for administering blood and medications are the primary parties affected by this recall.

7. How will Fresenius Kabi address the problem?
Fresenius Kabi will release a new software version for the Ivenix Large Volume Pump to rectify the existing software anomalies and ensure the safe and accurate delivery of fluids to patients.

8. Has Fresenius Kabi faced previous recalls with their Ivenix Infusion System?
Yes, Fresenius Kabi has faced a previous recall with their Ivenix Infusion System. The recall was labeled as Class I and was due to mechanical issues with fluid valve pins.

9. What role does the Ivenix Infusion System play in healthcare settings?
The Ivenix Infusion System is responsible for the controlled administration of fluids, medications, and blood products to both adult and pediatric patients in hospital and outpatient care environments.

10. What does the FDA recall remind the healthcare industry of?
The FDA recall serves as a reminder of the importance of vigilant quality control and risk management in the healthcare industry to ensure the safety and reliability of medical devices.

Definitions:

– FDA: The Food and Drug Administration is a regulatory agency in the United States responsible for protecting public health through the regulation and supervision of food, drugs, medical devices, and other products.

– Class I: Class I recall is the most serious type of recall issued by the FDA. It indicates that there is a reasonable probability that the use of or exposure to the recalled product will cause serious adverse health consequences or death.

Suggested Related Links:

1. FDA Website
2. FDA Medical Device Recalls
3. Fresenius Kabi Official Website