Catalog Number FNC3121 |
Device Problems
Leak/Splash (1354); Failure to Prime (1492); Split (2537)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Event Description
|
It was reported that the tubing of a clearlink system solution set split down the side.This occurred during priming and resulted in solution leaking to the floor.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
(b)(4).A request for the return of the device has been made.A batch review will be performed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
(b)(4).The device was not returned; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
(b)(4).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
|