MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOM; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050719

Device Problem Air Leak (1008)

Patient Problem Stroke/CVA (1770)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the perfusionist noted air bubbles on top of the fluid layer in the venous reservoir of the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir during a procedure.The device was used for the procedure.The patient suffered a stroke following the procedure.The device is not available to return, as it was discarded by the user before learning the patient had a stroke.The customer reported that the bubble detector never detected air and the perfusionist does not believe any was delivered to the patient.Cerebral o2 monitoring was in use during the procedure and that stats were normal throughout the case, so the customer does not believe the patient's condition was in any way caused by the performance of the oxygenator.The patient is currently awake and alert and the condition is improving.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Device discarded by user.

Event Description

Sorin group (b)(4) received a report that the perfusionist noted air bubbles on top of the fluid layer in the venous reservoir of the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir during a procedure.The device was used for the procedure.The patient suffered a stroke following the procedure.

Manufacturer Narrative

Sorin group (b)(4) manufactures the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the perfusionist noted air bubbles on top of the fluid layer in the venous reservoir of the inspire 6f dual hollow fiber oxygenator with integrated hardshell venous cardiotomy reservoir during a procedure.The device was used for the procedure.The patient suffered a stroke following the procedure.Though the unit was discarded by the user and an investigation could not be performed, a video sent to sorin group (b)(4) by the customer showed that the device had been set up with a suction tube containing air from the operating field connected to the non-activated suction port of the reservoir.This setup is contrary to what is advised in the instructions for use (ifu).In order to minimize gaseous microemboli activity, the ifu recommends avoiding the infusion of any fluid mixed with air through the non-activated blood suction port of the reservoir.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The complained issue was classified as a rare event, as no other similar cases have been reported.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Video received, device discarded by user.

• Brand Name: INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOM
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola, 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5680785
• MDR Text Key: 45958210
• Report Number: 9680841-2016-00363
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2018
• Device Catalogue Number: 050719
• Device Lot Number: 1507080007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2015
• 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): Other