MAUDE manufacturer profile

TERUMOBCT · LKN

MAUDE profile for Separator, Automated, Blood Cell And Plasma, Therapeutic

Key facts

Manufacturer TERUMOBCT
Manufacturer group TERUMO BCT
Product code LKN
Product code name Separator, Automated, Blood Cell And Plasma, Therapeutic

At a glance

  • 1–9 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Flow, Leak/Splash, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Bacterial Infection, No Known Impact Or Consequence To Patient 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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