Recall Z-2142-2016 ยท MEA Pump, Infusion, Pca
Hospira Inc.
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of
| 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 | 6,268 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
This recall record lists no 510(k) number.