Model Number 0998-00-0800-53 |
Device Problem
Leak/Splash (1354)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/17/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported, while visiting customer for normal education that the cardiosave intra-aortic balloon pump (iabp); cath lab manager, mentioned that one of their 4 pumps was lower on helium and at approx 1/2 tank while the other 3 where still full.Because these pumps are only a few months old and haven't been used, an assumption was made that this pump was leaking.I explained that 1 pump had been used for extensive education during install and that may explain the lower helium.Customer agreed that watching this pump was sufficient and that no other action was needed.There was no patient involvement.
|
|
Manufacturer Narrative
|
This complaint is being cancelled as it was opened in error.Revert all sections to blank : b.Adverse event or product problem d.Suspect medical device e.Initial reporter g.All manufacturers h.Device manufacturers only.
|
|
Event Description
|
This complaint is being cancelled as it was opened in error.
|
|
Search Alerts/Recalls
|