Recall Z-1365-2018 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Renal Therapies Group, LLC
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
| Date | Jan 24, 2018 |
| Status | Terminated |
| Reason | The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death. |
| Root cause | Software design |
| Action | On 01/25/2018, the recalling firm sent Urgent Medical Device Correction letters to affected Home Therapy Nurse Managers (HTNs). On 01/31/2018, the firm sent letters to affected patients. The letters informed customers of the recall and stated that patients who are considered "slow drainers" and experience M65 Scale warnings during one or more drain cycles are at increased risk. On 03/29/2018, the firm sent out a second Urgent Medical Correction Letter to HTNs, followed by a patient communication sent on 04/02/2018. In the second communication, the firm amended that slow drainers can develop O |
| Quantity | 9293 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171652 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC, Sep 15, 2017 |