MAUDE Adverse Event Report: MEDTRONIC, INC EVEREST INFLATION DEVICE 30ATM; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Catalog Number AC3200

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the everest inflation device was removed from packaging per ifu and inspected with no abnormalities noted.The device was prepped.It is reported that during use there was a sudden increase in pressure.No patient complications reported as a result of this event.

Manufacturer Narrative

Product analysis: received for analysis was one ac3200 everest device in a double bio bag with original packaging.The everest device was received with fluid in the barrel indicating use.The manometer reads 0atm as received.No signs of damage on the device were noted.During testing the needle moved steady to maximum pressure from 0atm to 30atm without issues.No leaks were detected during pressurization of the everest.The device maintained pressure for 3 minutes.During vacuum tests the needle returned to red as required.Special visual attention was given to the movement of the needle for indication of any movement.During testing the everest device was pressurized to different settings and left idle trying in recreating the reported event.All set pressure setting were steady exhibiting no decrease or increase in pressure.Test was completed resulting in the needle moving steady clockwise and counterclockwise without hesitation.A good faith effort will be made to obtain the applicable information relevant to the report.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.

• Brand Name: EVEREST INFLATION DEVICE 30ATM
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5722747
• MDR Text Key: 47311587
• Report Number: 1220452-2016-00041
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2018
• Device Catalogue Number: AC3200
• Device Lot Number: 50958885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1