MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 8F M

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

After the termination of cardiopulmonary bypass, the arterial temperature probe was removed from the temperature port.Blood was noticed on the temperature probe and inside the port.

Event Description

After the termination of cardiopulmonary bypass, the arterial temperature probe was removed from the temperature port.Blood was noticed on the temperature probe and inside the port.

• Brand Name: INSPIRE
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; 14401, west 65th way; arvada CO 80004
• MDR Report Key: 13598689
• MDR Text Key: 286125430
• Report Number: 13598689
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2022,01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8F M
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male
• Patient Weight: 81 KG