MEDTRONIC, INC EVEREST INFLATION DEVICE 30ATM; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Catalog Number AC3200 |
Device Problems
Leak/Splash (1354); Improper Device Output (2953)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/18/2017 |
Event Type
malfunction
|
Event Description
|
An everest device was being used during a procedure to treat a lesion in the renal artery.The device was removed from packaging, inspected and prepped per ifu with no issues noted.During use there was a manometer issue.The pressure was applied up to 30 atm, and the piston was locked.However, the pressure gauge indicated that the pressure was decreasing.The everest was connected to a balloon and a three-way stopcock.No injury reported.
|
|
Manufacturer Narrative
|
The everest was received with fluid in the syringe body.The stop cock from the everest kit and mating devices used in the case were returned for analysis with the inflation device.The everest was connected to the stopcock and the stopcock to one of the non-mdt 6.0x40mm balloon luer.As received the gauge needle is at -0 atm-, the plunger was pulled back and the needle returned to red as required.The everest syringe body, tube and lure rotator/connector all appear undamaged and without defect.The connections were taken apart and pressure/inflation function was tested on the returned everest inflation device and the device failed to hold pressure.A leak was detected during pressure testing, water exited the syringe thru cracks on the syringe threads.The needle moved normally while pressure was applied, but due to the detected leak the pressure was decreasing.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|