Recall -- Firm Press Release
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Hospira Issues A Voluntary Nationwide Recall Of Symbiq Infusion Systems Due To Inaccurate Response
Of The Touch Screen To User Selection/Input
FOR IMMEDIATE RELEASE - October 29, 2012 - Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide Class I recall of Symbiq™ infusion systems (list number 16026 Symbiq™ One-Channel Infuser and list number 16027 Symbiq™ Two-Channel Infuser, all serial numbers). This action is due to infusion pump LCD touch screens that may not respond to user selection, resulting in users possibly experiencing a delayed response and/or the screen registering a different value from the value selected by the user. Failure of the touch screen to respond properly to user input could potentially result in a delay or interruption in therapy, or over or under delivery of medication if the user confirms the incorrect values displayed on the pump's confirmation screen prior to starting the infusion. Hospira sent an urgent Medical Device Correction notice to impacted customers in August regarding this issue.
There is no need for facilities to return Symbiq infusers at this time. Hospira has advised healthcare providers to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. The company has notified healthcare providers using Symbiq that according to the device operating manual, users must confirm that the correct infusion pump programming information is selected and appears on the confirmation screen prior to proceeding with an infusion. Symbiq is designed with this confirmation screen to allow the clinician to double-check programming information prior to starting an infusion. If an additional mitigation is necessary, an infusion can be stopped by pressing the emergency stop hard button located above the touch screen on the front of the infuser or by pulling the cassette eject lever located on the bottom of the infuser. Hospira is sending customers an additional Medical Device Correction notice as a reminder of the appropriate action to take.
Hospira has completed an investigation into customer reports and has found the major contributor to be software related. Other contributing root causes that have been identified include damaged connections, physical damage and other touch screen defects.
The investigation has identified that the software-related root cause of this issue potentially impacts all Symbiq infusion systems currently in the field, and has been reported to Hospira for approximately 1.5 percent of Symbiq systems. The company is in the process of developing design improvements to correct the issue.
Once the design and development activities are complete, Hospira will notify customers and arrange for a device update. This product is only used by healthcare providers in hospitals and other healthcare facilities. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Healthcare providers experiencing the described issue should remove the impacted device from use and contact their institution's biomed or clinical engineering department to perform the touch screen test described in the Symbiq technical service manual. If the biomed or clinical engineering department identifies that the device is not working properly, contact Hospira:
Areas of Support
1-800-441-4100 (8 a.m. – 5 p.m. CST, M-F) (ProductComplaintsPP@hospira.com)
To report adverse events or product complaints
Additional information or technical assistance
Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.
- Online: http://www.fda.gov/medwatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA3500 available at http://www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
Hospira customers have been asked to complete and return a reply form reconfirming the number of Symbiq infusers at their facility. This information will be used to contact healthcare providers once the device correction is available. Customers who need additional copies of the reply form should contact Stericycle at 1-877-272-6141 (8 a.m. – 5 p.m. EST, M-F).
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. Learn more at http://www.hospira.com.