The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospita

FDA device recall Z-0350-2014 · posted 2013-11-21 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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 Hospira7906@stericycle.com. 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

Status

Terminated

Product code

FRN

Quantity affected

43,840

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, S

Date initiated

2013-03-15

Date posted

2013-11-21

Date terminated

2017-03-07

Location

Lake Forest, IL

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