12

Jun

2019

Recall – Implantable pump shuts down unexpectedly under certain conditions

recall, softwareerror

0

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

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