Terminated

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.

FDA Recall Z-0349-2014 · Posted 2013-11-21

Recalling FirmHospira Inc.

Recall StatusTerminated

Product CodeFRN

Date Initiated2013-03-15

Date Terminated2017-03-07

Product Quantity1) List Number 13000: 2,162 pumps; 2) List Number 13100: 15 pumps; 3) List Number 13150: 1,955 pumps

Reason for Recall

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 occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.

Firm 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 customers that the proximal and distal occlusion tests should be performed on an annual basis as a part of the yearly GemStar maintenance schedule. Customers were also requested to complete and return the attached reply form and return it to Hospira by fax to 1-888-714-5077 or by e-mail to [email protected]. Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. For questions regarding this recall call 800-441-4100.

Root Cause

Device Design

Distribution Pattern

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 Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060806HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088Hospira, Inc. · 2006-04-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.