MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH THE STOCKERT HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number CP_IFU_16-XX-XX_USA_018

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

Patient Problems Unspecified Infection (1930); Pleural Effusion (2010)

Event Date 05/21/2018

Event Type  Injury  

Event Description

Possible ntm pt infection from 3t heater cooler device: pt underwent robotic single vessel cabg 5/21.Chest tube removed pod#3 and discharged 5/24 a livanova (sorin) heater cooler unit was in the operating room and turned on for the 5/21 case, although it was not used to cool/heat the pt.Specific unit used was not known at that time.Id physician at (b)(6) notified musc infection prevention and control by email 6/20 that the pt had been admitted there 6/5-6/18 with a pleural effusion, pneumonia, and large pericardial effusion.

• Brand Name: THE STOCKERT HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH
• MDR Report Key: 8045965
• MDR Text Key: 126526683
• Report Number: MW5081103
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CP_IFU_16-XX-XX_USA_018
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 116