MAUDE Adverse Event Report: MEDTRONIC, INC EVEREST SURVIVAL KIT-30ATM; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Catalog Number AC3205P

Device Problems Inflation Problem (1310); Device Inoperable (1663); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure three everest inflation devices failed to work.The needle in all three devices failed to move.No patient injury occurred.

Manufacturer Narrative

Evaluation, results: (root cause cannot be confirmed - device not returned for evaluation); conclusion: unable to confirm complaint (root cause cannot be confirmed - device not returned for evaluation).(b)(4).

Manufacturer Narrative

Result: melted plastic, stress cracks, rust.Possible re-use of device.Conclusion: could not replicate reported failure mode due to condition of returned device.

Event Description

Device evaluation: analysis of the returned everest inflation devices suggest the devices may have been exposed to conditions beyond single use in a clinical setting.The damage seen indicates exposure to excessive heat or multiple uses.Everest device exhibits one or more conditions consistent with rust, melted plastic, surface scratches, corrosion and stress cracks.

• Brand Name: EVEREST SURVIVAL KIT-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.; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 3918933
• MDR Text Key: 15111557
• Report Number: 1220452-2014-00039
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K960983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: AC3205P
• Device Lot Number: 50770392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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