MAUDE manufacturer profile

MAQUET CARDIOPULMONARY GMBH · KDI

MAUDE profile for Dialyzer, High Permeability With Or Without Sealed Dialysate System

Key facts

Manufacturer MAQUET CARDIOPULMONARY GMBH
Manufacturer group JULIA KAPFENBERGER
Product code KDI
Product code name Dialyzer, High Permeability With Or Without Sealed Dialysate System

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Fluid/Blood Leak, Leak/Splash, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Filtration Problem, Packaging Problem, Device Operates Differently Than Expected 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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