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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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