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