Catalog Number 955596 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/28/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that during priming with two (2) units of prismaflex st150 sets, an external fluid leakage was observed.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
Prismaflex st150 set c has been temporarily approved for use in the us under emergency use authorization eua (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
The actual device was not returned for evaluation, however, a picture was returned.Inspection did not verify the reported condition.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|