Catalog Number 107144 |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/16/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that an external fluid leak was observed from a weak connection at the lower tube between the lower header of the filter housing and post pump segment of a prismaflex tpe2000.The event occurred during priming.A there was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
H10: the device was received for evaluation.The visual inspection of the provided sample showed a cut on the access line near the screwed connector.The reported condition was verified.The cause could not be determined.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
|