Recall Z-0353-2017 ยท FRN Pump, Infusion
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
| Date | Feb 5, 2013 |
| Status | Terminated |
| Reason | 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 backu |
| Root cause | Process control |
| Action | Hospira sent an Urgent Field Device Correction letter dated Feburay 5, 2013, to all affected customers. Hospira has implemented a correction to the manufacturing process to address this issue. Symbiq v3.13 pumps that have been shipped from Hospira since September 2012 and pumps that were upgraded to v3.13 in the Field after September 2012 are not impacted by this issue. If you are unsure of when you were shipped Symbiq v3.13 pumps or when your devices were upgraded, contact Hospira. Please complete the attached reply form and return it via fax number or e-mail address on the form |
| Quantity | 20,311 |
| Distribution | Nationwide Distribution and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET Hospira, Inc., Mar 5, 2012 |