MAUDE Adverse Event Report: SORIN GROUP USA, INC. SORIN S5 HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number S5

Device Problem Failure to Power Up (1476)

Patient Problem Death (1802)

Event Date 11/04/2015

Event Type  Death  

Event Description

Going on cardiopulmonary bypass, adjustments on sterile field made to double cannulate heart for more flow.Md asked perfusionist to prime line to expel air so he could re-cannulate and fill heart to resume cardiopulmonary bypass.Flow from bypass machine would not re-start.Md began open heart compressions.Perfusionist unable to re-start prime on pump to restore flow.Patient expired.

• Brand Name: SORIN S5 HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 5450398
• MDR Text Key: 38642475
• Report Number: 5450398
• Device Sequence Number: 0
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2016,01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: S5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR