Model Number IPN000262 |
Device Problems
Material Puncture/Hole (1504); Gas/Air Leak (2946)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/25/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that after the intra-aortic balloon (iab) was implanted by the doctor, the intra-aortic balloon pump (iabp) gave a helium leak alarm and there was no pressure counterpulsation waveform.As a result, a new iab was used and inserted into the same insertion site to complete the treatment successfully.There was no report of patient complications, serious injury or death.
|
|
Event Description
|
It was reported that after the intra-aortic balloon (iab) was implanted by the doctor, the intra-aortic balloon pump (iabp) gave a helium leak alarm and there was no pressure counterpulsation waveform.As a result, a new iab was used and inserted into the same insertion site to complete the treatment successfully.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex received the device for investigation.The reported complaint of iab helium loss alarm is not able to be confirmed.The returned iabc bladder was fully intact.No alarms were noted during the functional testing.The returned catheter passed functional test specifications.The root cause of the complaint 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.
|
|
Search Alerts/Recalls
|