Recall Z-0439-2021
Fresenius Medical Care Holdings, Inc. · initiated September 12, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Codes / lots: All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343
Reason for recall
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
FDA-determined cause: Device Design
Action taken
On September 16, 2020, Urgent Medical Device Correction notices and response forms were issued to home therapy nurse managers and patients. Patients using a Liberty Select cycler with software version 2.9.0 are instructed to disable the Flow Alert option. Patients will no longer receive on an-screen Flow Alert message or an audible Flow Alert series of beeps. Instructions for disabling the Flow Alert alarm are included in the notification letter. Patients should continue to use their Liberty Select Cycler for treatment with the Flow Alert option set to "No". Fresenius Medical Care LLC is not requesting the return of the Liberty Select cyclers software version 2.9.0. Replacing the Liberty Select cycler will not resolve this issue. Please complete and return the enclosed Reply Form, indicating receipt and understanding of the communication and actions to take. For additional information, please call 1-855-616-2309 Monday - Friday 8:30 am-5 pm, EST or submit an online request any time at www.fmcna-medinfo.com.
Details
- Recall number
- Z-0439-2021
- Initiated
- September 12, 2020
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 9,907 devices
- Distribution
- Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA