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U.S. Department of Health and Human Services

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

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SORIN GROUP ITALIA S.R.L. INSPIRE 8 DUAL DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameINSPIRE 8 DUAL DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR
Type of DeviceOXYGENATOR, 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 Key6403391
MDR Text Key69893779
Report Number9680841-2017-00008
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K121229
Number of Events Reported1
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 Received03/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/04/2019
Device Catalogue Number050718
Device Lot Number1602040197
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/14/2017
Device Age1 YR
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2016
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
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