FDA-Device2019-06-12Class II
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Flowonix Medical Inc
Hazard
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
Sold states
US nationwide distribution.
Affected count
809
Manufactured in
120 Forbes Blvd Ste 170, Mansfield, MA, United States
Products
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1714-2019Don't want to check this manually?
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