Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH |
Device Problem
Corroded (1131)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
|
Event Date 08/12/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Trackwise id#: (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
|
|
Event Description
|
The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, barrage was first sterilized according to specifications.Flash rust adherence after sterilization.No patient involvement.
|
|
Event Description
|
The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, barrage was first sterilized according to specifications.Flash rust adherence after sterilization.No patient involvement.
|
|
Manufacturer Narrative
|
H6 correction: patient codes changed to no patient involvement.Internal complaint number: (b)(4).The device was returned to the factory on 09/14/2020.An investigation was conducted on (b)(6) 2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There is evidence of corrosion observed on the device itself.The trade name maquet on the device as well as on the teeth of the device appeared to be brown resembling rust or corrosion.No other visual defects were observed.Based on the returned condition of the device, the reported failure "corrosion" was confirmed.
|
|
Search Alerts/Recalls
|