Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1714-2019 — Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.

U.S. FDA — Device Enforcement · United States · 2019-03-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1714-2019
Date of alert
2019-03-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Flowonix Medical Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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