FDA-Device2016-11-09Class II

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026

Hospira Inc.

Hazard

Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.

Sold states

Nationwide Distribution and Canada

Affected count

20,311

Manufactured in

275 N Field Dr, Lake Forest, IL, United States

Products

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2017

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