Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall
[UPDATED 09/21/2010] There is potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally, when unrestricted flow occurs, the “Check Flow Stop” alarm, which is designed to notify users of a free flow condition, may not function as intended and may not provide appropriate warning to users. Unrestricted flow of medication an/or other therapy has the potential to cause life-threatening effects and/or critical patient injury, especially in specific patient groups such as critically ill patients, patients with congestive heart failure and/or neonates. The design of this device is being evaluated. The actions required under this recall will be supplemented with a long term solution to the “Check Flow Stop” alarm malfunction on a later date.
AUDIENCE: Risk Manager
ISSUE: Potential for the device to fail to detect air in line at the end of an infusion. Failure to detect air in line may result in the delivery of air to the patient, resulting in serious injury or death.
BACKGROUND: The Symbiq Infusion System is an infusion pump intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
RECOMMENDATION: Hospira mailed clinical bulletins to affected customers on April 9, 2010, and an updated clinical bulletin on June 11, 2010. In the June 11, 2010 letter, Hospira states the user does not have to remove or stop using the Symbiq infusion pump, and provided recommended mitigation actions.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178