MAUDE report

MAUDE report 70368: VOLUMETRIC PUMP SOLUTION SET

Malfunction · received Feb 14, 1997 · BAXTER HEALTHCARE CORP.

Key facts

MDR report key 70368
Report number 6000001-1997-00043
Event type Malfunction
Brand name VOLUMETRIC PUMP SOLUTION SET
Catalog number 2C1031N
Manufacturer BAXTER HEALTHCARE CORP.
Product code FPA
Device class Class II
Date received by FDA Feb 14, 1997
Report date Jan 17, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

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

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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