Catalog Number H938740 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/03/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that an exactamix 2000 ml eva tpn bag was leaking at the connector.The leak was discovered at the dispensing room before patient treatment.The was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed and identified a leak from the fill port tubing weld.The reported condition was verified.The cause of the condition could not be determined.This issue is being further investigated.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
|