medical Class II Updated 2019-06-12

Flowonix Medical Inc recalls Prometra Programmer (Grand Prime) Software version 2.00.29,

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software v.2.00.29 Serial numbers: D18L0003 D18L0022 D18L0013 D18L0035 D18L0004 D18L0025 D18L0014 D18L0036 D18L0006 D18L0026 D18L0015 D18L0037 D18L0010 D18L0027 D18L0016 D18L0038 D18L0009 D18L0028 D18L0017 D18L0034 D18L0008 D18L0029 D18L0018 D18L0039 D18L0007 D18L0030 D18L0019 D18L0040 D18L0011 D18L0031 D18L0021 D18L0041 D18L0005 D18L0032 D18L0023 D18L0042 D18L0012 D18L0033 D18L0024 D18L0020
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