MAUDE manufacturer profile

B. BRAUN AVITUM AG - MELSUNGEN · FKJ

MAUDE profile for Filter, Blood, Dialysis

Key facts

Manufacturer B. BRAUN AVITUM AG - MELSUNGEN
Manufacturer group B. BRAUN AVITUM AG - MELSUNGEN
Product code FKJ
Product code name Filter, Blood, Dialysis

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Filtration Problem, No Consequences Or Impact To Patient, Cramp(s), Calibration Problem, Hypernatremia, Device Alarm System, Inadequate Ultra Filtration, Sweating 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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