MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8 DUAL DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	050718
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Death (1802)
Date of Event	02/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient sex was not provided.Patient weight was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of event.Event problem codes are listed in report.(b)(4).Per exemption number e2016005.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The customer has not clarified the involvement of the device in the reported event.Several attempts have been made to contact the customer.No additional information has been provided.The device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Sorin group (b)(4) received a report that massive arterial air embolism occurred while using inspire 8 dual hollow fiber oxygenator.The patient has expired.

• Brand Name: INSPIRE 8 DUAL DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• MDR Report Key: 6403391
• Report Number: 9680841-2017-00008
• Device Sequence Number: 663219
• Product Code: DTZ
• UDI-Device Identifier: 08033178112406
• UDI-Public: (01)08033178112406(17)190204(10)1602040197
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 050718
• Device Lot Number: 1602040197
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/14/2017
• Device Age: 1 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR