FDA-Device2019-06-12Class II
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. 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.
Sold states
US nationwide distribution.
Affected count
318
Manufactured in
120 Forbes Blvd Ste 170, Mansfield, MA, United States
Products
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1712-2019Don't want to check this manually?
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