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

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.

• Brand Name: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO
• Type of Device: OXYGENATOR, 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 Key: 5386567
• MDR Text Key: 36685750
• Report Number: 9680841-2015-00675
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• 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 Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: IN00692H
• Device Lot Number: 1507160050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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
• Patient Outcome(s): Death