BAXTER HEALTHCARE CORPORATION; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
|
Back to Search Results |
|
Catalog Number ASKU |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that an external fluid leak was observed with a prismaflex st150 set.It was further reported, the "return line leaking large amount of fluid, not at connection, it seems to be above the connection despite no visible crack or break in the line.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|