MAUDE manufacturer profile

INFUTRONIX, LLC · FRN

MAUDE profile for Pump, Infusion

Key facts

Manufacturer INFUTRONIX, LLC
Manufacturer group INFUTRONIX, LLC
Product code FRN
Product code name Pump, Infusion

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Complete Loss of Power, Mechanical Problem, Problem with Software Installation, Infusion or Flow Problem, Inaccurate Delivery, Insufficient Flow or Under Infusion, Device Alarm System Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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