MAUDE manufacturer profile

TERUMO CORPORATION, ASHITAKA · DTR

MAUDE profile for Heat-Exchanger, Cardiopulmonary Bypass

Key facts

Manufacturer TERUMO CORPORATION, ASHITAKA
Manufacturer group TERUMO CORPORATION, ASHITAKA
Product code DTR
Product code name Heat-Exchanger, Cardiopulmonary Bypass

At a glance

  • 10–99 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Leak/Splash, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Material Separation, No Patient Involvement, Detachment of Device or Device Component, Gas/Air Leak 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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