MAUDE Adverse Event Report: SORIN GROUP USA, INC. / LIVANOVA USA, INC. SORIN 3T HEATER COOLER (NOW LINOVA); CONTROLLER, TEMPERATURE, CADIOPULMNARY BYPASS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 05/11/2015

Event Type  Death  

Event Description

Pt exposed to sorin 3t heater cooler during cardiac surgery.Serial numbers continued: (b)(4).Unsure what machine was used on (b)(6) 2015.

• Brand Name: SORIN 3T HEATER COOLER (NOW LINOVA)
• Type of Device: CONTROLLER, TEMPERATURE, CADIOPULMNARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC. / LIVANOVA USA, INC. ; arvado CO
• MDR Report Key: 8208310
• MDR Text Key: 131901042
• Report Number: MW5082707
• Device Sequence Number: 4
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/20/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR