# P080012: Prometra Programmable Infusion Pump System

- Pathway: PMA
- Applicant: Infusyn Therapeutics, LLC
- Decided: Feb 7, 2012 after 1,397 days
- Product code: LKK (Pump, Infusion, Implanted, Programmable)
- Device class: 3
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 26, 2021 · Class II · Z-1996-2021: Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reu
- Dec 24, 2019 · Class II · Z-1125-2020: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of
- Dec 24, 2019 · Class II · Z-1123-2020: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of
- Dec 24, 2019 · Class II · Z-1121-2020: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of
- Dec 24, 2019 · Class II · Z-1120-2020: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of
- Dec 24, 2019 · Class II · Z-1124-2020: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of
- Dec 24, 2019 · Class II · Z-1122-2020: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of
- Mar 21, 2019 · Class II · Z-1713-2019: 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
- Mar 21, 2019 · Class II · Z-1712-2019: 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
- Mar 21, 2019 · Class II · Z-1714-2019: 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
- Mar 21, 2019 · Class II · Z-1716-2019: 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
- Mar 21, 2019 · Class II · Z-1715-2019: 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
- May 22, 2017 · Class II · Z-2740-2017: Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-ap

Source page: https://510kreport.com/device/P080012
Methodology: https://510kreport.com/methodology