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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Death (1802)

Event Date 02/01/2017

Event Type  Death  

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). 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 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
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6403391
• MDR Text Key: 69893779
• Report Number: 9680841-2017-00008
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178112406
• UDI-Public: (01)08033178112406(17)190204(10)1602040197
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 050718
• Device Lot Number: 1602040197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 02/14/2017
• Device Age: 1 YR
• Event Location: No Information
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/14/2017 Patient Sequence Number: 1