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Flowonix Medical Inc recalls Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Recalled June 12, 2019 · FDA recall Z-1714-2019 · Flowonix Medical
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. · FDA Class II
Units
809
Sold at
US nationwide distribution.
Description
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.
Product
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Manufacturer(s)
Flowonix Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →