Flowonix recalls Prometra Programmable Pump (Cat. No. 11827) for intrathecal infusion due to unexpected shutdowns when Error 115 occurs, caused by software defects in specific programming scenarios.
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.
Flowonix is recalling its Prometra Programmable Pump (Cat. No. 11827) for intrathecal infusion because a software defect can cause it to shut down unexpectedly when Error 115 is triggered. This error can happen if a healthcare provider programs a Bridge or Demand bolus using Clinician Programmer Software Version 2.00.29 while the pump is set to Periodic Flow or Multiple Rates mode, or if dendrites form or the pump is dropped.
The pump can shut down unexpectedly when Error 115 occurs, which is triggered by a software defect. This defect happens if a healthcare provider uses Clinician Programmer Software Version 2.00.29 to program a Bridge or Demand bolus while the pump is in Periodic Flow or Multiple Rates mode. Dendrites forming or dropping the pump can also cause Error 115.
Patients using this pump for intrathecal infusion and healthcare providers who program it with the specified software version. Those who have the pump set to Periodic Flow or Multiple Rates modes are at higher risk.
Check the pump's serial number against the list provided: 10AX4A03, 10BY4A40, 10EY4A35, and other serial numbers listed in the recall notice. This pump is for intrathecal infusion and was sold with specific software versions.
Compare your pump's serial number to the list provided in the recall notice to confirm if it is affected.
The pump can shut down unexpectedly when Error 115 occurs, which is caused by a software defect when programming with Clinician Programmer Software Version 2.00.29 in specific modes.
Check your pump's serial number against the list provided in the recall notice. If it's affected, contact Flowonix for further instructions.
The recall does not specify a fix; the official notice only states that the pump may need to be checked or replaced if it has the affected serial numbers.
We’ve drafted a message you can send Flowonix to request your refund or repair — edit it as you like.
Subject: Recall Z-1714-2019 — Flowonix Flowonix Hello, I own a Flowonix that is covered by recall Z-1714-2019 from Flowonix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
