Recall Z-0849-2019 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corporation
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
| Date | Dec 11, 2018 |
| Status | Terminated |
| Reason | Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy |
| Root cause | Software design |
| Action | Baxter Healthcare Corporation notified providers on about 12/11/2018 of the recall concerning the AMIA Automated Peritoneal Dialysis System, via "Urgent Medical Device Correction" letter. Patients were notified on about 1/14/2018 via "Urgent Medical Device Correction" letter. Providers were instructed to continue using the AMIA Automated PD System however, for patients who are prescribed a Cycle-Based therapy, to change these therapies to Time-Based by following the programming instructions within the Clinician Guide, Section 5.3.1 - Time-Based Programming Method. In Time-Based therapy, t |
| Quantity | 7,688 devices |
| Distribution | Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151525 | Amia Automated PD System with Sharesource Deka Research and Development, Oct 9, 2015 |