Flowonix Prometra Programmer Software Recall for Unexpected Pump Shutdowns
Flowonix Medical Inc is recalling 40 units of Prometra Programmer software due to a defect that causes intrathecal pumps to shut down unexpectedly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the unexpected shutdown of a medical device used for intrathecal infusion, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Flowonix Medical Inc is recalling 40 units of Prometra Programmer (Grand Prime) Software version 2.00.29, Catalog Number 13828. This software is used with Prometra and Prometra II Programmable Pumps for intrathecal infusion. The affected units were distributed nationwide in the United States.
The recall is due to a software defect that causes the pump to shut down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. The frequency of these errors has increased when a Healthcare Provider uses the Clinician Programmer software to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
Healthcare providers and patients using the affected software should contact Flowonix Medical Inc for further instructions on how to address the software defect and ensure the safety of their intrathecal infusion therapy.
The recalled product
- Product
- Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 40
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Flowonix Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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