Flowonix Prometra Clinician Programmer Software Recall for Unexpected Pump Shutdowns
Flowonix Medical Inc is recalling Prometra Clinician Programmer software due to a defect that can cause intrathecal pumps to shut down unexpectedly.
What this means for you
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 involves a medical device defect that can lead to unexpected shutdown of an intrathecal infusion pump, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Flowonix Medical Inc is recalling 318 units of the Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Catalog Number 12828. 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 can cause the pump to shut down unexpectedly. This occurs if Error 115, an alarm associated with a watchdog timer timeout, is triggered. The defect is caused by using the specific software version to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
Healthcare providers should check their inventory for the affected serial numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to Flowonix Medical Inc for repair or replacement. Patients using these pumps should contact their healthcare provider to ensure their device is not affected and to discuss any necessary adjustments to their treatment plan.
The recalled product
- Product
- Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
- Manufacturer
- Flowonix Medical Inc
- Affected units
- 318
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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