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.
Recall
- Recall Number
- Z-2139-2016
- Event Number
- 68318
- Firm
- Hospira Inc.
- FEI Number
- 3013319212
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- March 8, 2013
- Terminated
- November 7, 2016
- Address
- 275 N Field Dr, Lake Forest, IL, 60045-2579
Description
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.
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.
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 servicing. The letter advised the Hospira is in the process of establishing a useful life for the half nut and to determine when it will require replacement. A new Technical Service Manual will be issued in late 2014 that adds a requirement for annual PVT Occlusion testing. The System Operating Manual will include new instructions to reduce the excessive wear on the half nut resulting from incorrectly using the vial information. Customers who further distributed the devices are requested to notify their customers of the recall and ask them to call Stericycle at 888-965-5801 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. Questions about this recall should be direct to Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST).
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:
53,151 infusion pump systems