Device product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
Z-0069-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 63056
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19,614 units
- Official record key
device-enforcement:Z-0069-2013
Official wording
Reason: The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
Code information: List Number 16026-01, all serial numbers
Distribution pattern: Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
Derived failure modes
-
Unknown
The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.