Recall Z-0349-2014 ยท FRN Pump, Infusion
Hospira Inc.
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
| Date | Nov 21, 2013 (initiated Mar 15, 2013) |
| Status | Terminated |
| Reason | The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected |
| Root cause | Device Design |
| Action | Hospira sent an Urgent Device Field Correction letter dated March 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter asks that customers immediately perform proximal and distal occlusion tests as defined i nthe GemStar Technical Service Manual. If the device fails either of the tests, remove it from clinical service and contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM) to report the issue and arrange for the return of the device for recalibration. The letter further reminds customer |
| Quantity | 1) List Number 13000: 2,162 pumps; 2) List Number 13100: 15 pumps; 3) List Number 13150: 1,955 pumps |
| Distribution | Worldwide Distribution - USA including 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. Internationally to Australia, New Zealand, China, Hong K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 Hospira, Inc., Apr 21, 2006 |