Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
- Company
- Flowonix Medical Inc
- Recall Initiated
- December 24, 2019
- Posted
- February 10, 2020
- Recall Number
- Z-1124-2020
- Quantity
- 1083 (OUS)
- Firm Location
- Mansfield, MA
Reason for Recall
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 tolerance" conditions associated with the pump's valve system.
Distribution
Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
Lot / Code Info
All units with pump firmware version 0.26 manufactured from 2012 until the present time.
Root Cause
Software change control
Action Taken
***Updated 5/12/2023*** On May 11, 2023, the firm sent an URGENT MEDICAL DEVICE CORRECTION UPDATE letter to all affected customers, which informed them of an update to Flowonix's plan to correct the firmware issue. Flowonix will NOT be conducting an office-based pump firmware update for affected pumps implanted prior to January 2020. Healthcare providers were provided ongoing recommendations for Prometra and Prometra II pumps implanted prior to January 2020, which are impacted by this issue. Healthcare providers should contact their Flowonix Representative or our Technical Solutions Department (1-855-356-9665) in the event cessation of therapy or premature low battery is suspected and/or have general questions regarding this notice. *** On December 24, 2019, the firm notified affected users via an Urgent Medical Device Corrective Action Recall Notice. The firm advised customers of the product issue and reminded customers that the pumps are currently labeled only for use with Infumorph. Due to the low risk that this failure mode may occur, Flowonix is not recommending that pumps be explanted. Healthcare providers were recommended to inform patients regarding the symptoms and adverse health events associated with an unexpected pump stoppage and the appropriate steps to take in the event they suspect a stoppage. The firm will be implementing a correction of firmware errors to bring the pumps back into specification. The firm will follow up when the change has been completed. An office-based pump firmware update is being developed for patients currently implanted with the affected pumps. (Note, as of the 5/12/23 update, implanted pumps will not be receiving a firmware update.)