MAUDE report

MAUDE report 30615: PCA PUMP

Injury · received Jan 24, 1996 · BAXTER HEALTHCARE CORP.

Key facts

MDR report key 30615
Report number 30615
Event type Injury
Brand name PCA PUMP
Model number PCA II
Catalog number 6464602
Manufacturer BAXTER HEALTHCARE CORP.
Product code MEA
Device class Class II
Date received by FDA Jan 24, 1996
Report date Dec 1, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 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:

Browse all MAUDE medical device reports