Recall Z-2139-2016 ยท FRN Pump, Infusion
Hospira Inc.
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.
| Date | Mar 8, 2013 |
| Status | Terminated |
| Reason | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion. |
| Root cause | Component design/selection |
| Action | Hospira sent an IMPORTANT DEVICE INFORMATION letter dated March 8, 2014 to all affected customers.. The letter advised customers to: 1) Perform the Performance Verification Test (PVT) Occlusion Test as defined in the PCA Technical Service Manual (TSM); 2) If the device does not pass the test, remove it from clinical service and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue; and 3) Perform the appropriate troubleshooting and repair activities defined by your facility, which may include returning the device to Hospira for further diagnosing and serv |
| Quantity | 53,151 infusion pump systems |
| Distribution | Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, 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) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912928 | LIFECARE 4100 PCA INFUSER PLUS II Abbott Laboratories, Aug 26, 1991 |