|
Catalog Number 0998-00-0800-53 |
Device Problem
Air Leak (1008)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/07/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.The company service territory manager (stm) evaluated the iabp and ran the helium leak test twice.Both times it was at 51 psig which is within specification.The iabp passed all calibration, functional and safety tests that were performed.The iabp was returned to the customer and released for clinical use.
|
|
Event Description
|
The customer reported that, prior to use on a patient, it was discovered that the cardiosave had a helium leak.No patient involvement or adverse event reported.
|
|
Search Alerts/Recalls
|
|
|