The FDA issued an early alert last Monday regarding potential safety issues identified with the AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit produced and distributed by Nuwellis. The FDA’s alert followed a safety warning sent by Nuwellis to health care providers.
The AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit (UDI # 10853072007111) is intended for use with the Aquadex SmartFlow Systems. According to Nuwellis, health care providers use the Aquadex SmartFlow Systems to “slowly and gently remove excess water and sodium” from patients with fluid overload. In such patients, administration of diuretics has been insufficient to address water and sodium retention.
Due to safety issues, Nuwellis has recommended that health care providers remove 24 lots of the AquaFlexFlow UF 500 Plus extracorporeal blood circuits from use. The lot numbers included in the suggested recall are as follows: 22697, 22698, 22699, 22700, 22701, 22702, 22703, 22704, 22705, 22706, 22707, 22708, 22721, 22722, 22723, 22724, 22733, 22734, 22735, 22736, 22737, 22738, 22739, and 22740. The model number for the affected product is 114156 with a catalog number of A06163. Facilities and health care providers can find the lot number clearly listed in the middle column of the product label for the AquaFlexFlow UF 500 Plus extracorporeal blood circuits.
When Nuwellis issued the safety letter, they had received three reports of injury associated with use of the AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit. The company indicates that the device is at risk of halting therapy while in use due to an issue with the device’s console alarms. Specifically, the console may signal “Ultrafiltrate Weight Mismatch” or “Excessive Weight Mismatch” alarms simultaneously, which may then cause the console to end treatment during filtration. This can result in “acute volume depletion” and the need for additional therapy with another filtration unit.
Nuwellis urges medical providers to identify all affected units of the AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit and to cease use of the machines immediately. Both Nuwellis and the FDA will continue to monitor and investigate safety issues with the device.
Patients and health care providers can report any new adverse health events related to use of the AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to safety issues with a medical device, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to hospitals and health care providers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.