Model Number IPN000252 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/14/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the staff noted blood in the gas line when the intra-aortic balloon (iab) was in use.The intra-aortic balloon pump (iabp) was stopped and the iab was removed by the doctor prior to cabg.The patient had a bypass and no second iab was used.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
Qn# (b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is confirmed.Based on the customer video provided with the complaint report, blood is confirmed within the iab helium pathway; the root cause of how the blood entered the helium pathway is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
|
|
Event Description
|
It was reported that the staff noted blood in the gas line when the intra-aortic balloon (iab) was in use.The intra-aortic balloon pump (iabp) was stopped and the iab was removed by the doctor prior to cabg.The patient had a bypass and no second iab was used.There was no report of patient complications, serious injury or death.
|
|
Search Alerts/Recalls
|