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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number IN00692H
Device Problem Device Issue (2379)
Patient Problem Air Embolism (1697)
Event Date 11/19/2015
Event Type  Death  
Manufacturer Narrative
The inspire 8f m hollow fiber oxygenator was assembled into a customized circuit that is not distributed in the usa, but it is similar to the sterile oxygenator that is distributed in the usa (510k#: (b)(4)). The unit and the circuit have been discarded at the customer site. Sorin group (b)(4) manufactures the inspire 8f m hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). This medwatch is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that, during a coronary artery bypass surgery requiring ecc, air was delivered to the patient while using an inspire 8f m hollow fiber oxygenator assembled into a customized circuit. The patient has died on (b)(6) 2015. The investigation is on going. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that, during a coronary artery bypass surgery requiring ecc, air was delivered to the patient while using an inspire 8f m hollow fiber oxygenator assembled into a customized circuit. The patient has died on (b)(6) 2015.
 
Manufacturer Narrative
(b)(6) patient sex: female. (b)(6). Sorin group (b)(4) manufactures the inspire 8f m hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). (b)(4). Sorin group (b)(4) received a report that, during a coronary artery bypass surgery requiring ecc, air was delivered to the patient while using an inspire 8f m hollow fiber oxygenator assembled into a customized circuit. The patient has died on (b)(6) 2015. The unit and the circuit were discarded by the customer, so the device could not be returned for investigation. Sorin group (b)(4) reviewed the dhr and was unable to identify any deviations or non-conformities relevant to the issue. The disposables were compliant with sorin group (b)(4) specifications when released. Because the device was not returned and an investigation could not be performed, a root cause could not be identified. Based on the analysis of the available information and the outcome of the internal investigation, no device malfunction was identified. The hlm machines and the respective bubble sensors available at the medical center were also verified by the manufacturer, sorin group (b)(4), and were all found to be conforming to specifications. No malfunction of a sorin manufactured device was identified as a cause or contributing factor to the reported event. There have been no other complaints for this type of issue involving the inspire oxygenator or the complained circuit. Sorin group (b)(4) will continue to monitor for trends related to this issue.
 
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Brand NameHOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola (modena), italy 41037
IT 41037
Manufacturer (Section G)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola (mo), italy 41037
IT 41037
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5386567
MDR Text Key36685750
Report Number9680841-2015-00675
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIN00692H
Device Lot Number1507160050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2015
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: 01/22/2016 Patient Sequence Number: 1
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