MAUDE Adverse Event Report: LIVANOVA PLC STOCKERT 3T HEATER-COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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

Patient Problems Fatigue (1849); Fever (1858); Granuloma (1876); Unspecified Infection (1930); Weight Changes (2607)

Event Date 04/28/2016

Event Type  Injury  

Event Description

Sorin heater-cooler issue: suspicion of ntm infection related to aortic valve replacement in (b)(6) 2016.The patient has many concerning symptoms (fevers, fatigue, weight loss) and labs (pancytopenia, lft elevation), as well as a recent bone marrow biopsy showing granulomas, suggestive of an atypical infectious process.

• Brand Name: STOCKERT 3T HEATER-COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA PLC; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 8050655
• MDR Text Key: 126555703
• Report Number: 8050655
• Device Sequence Number: 1
• Product Code: DWC
• 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: 10/30/2018,10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 24090 DA