Recall – Implantable pump shuts down unexpectedly under certain conditions

Company: Flowonix Medical Inc
Date of Enforcement Report: 6/12/2019
Class II

PRODUCT

Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.

Recall Number: Z-1712-2019

Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.

Recall Number: Z-1713-2019

Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.

Recall Number: Z-1714-2019

Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.

Recall Number: Z-1715-2019

Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.

Z-1716-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Flowonix Medical Inc on 3/21/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
318

DISTRIBUTION

US Nationwide

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.