MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH/LIVANOVA USA, INC. STOCKERT HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY

Catalog Number 16-02-85

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

Patient Problems Bacterial Infection (1735); Fatigue (1849); Hepatitis (1897); Weakness (2145); Arthralgia (2355); Sweating (2444); Weight Changes (2607)

Event Date 10/30/2018

Event Type  Injury  

Event Description

On (b)(6) 2016: operative procedure - redo sternotomy and mitral valve repair.On (b)(6) 2018: liver biopsy revealed mild to moderate active (b)(6) with associated non-necrotizing granulomas (afb stains negative for afb and no fungal elements seen).On (b)(6) 2018: chest ct revealed granuloma in the right mid-lung.Bronchial specimen collected (b)(6) 2018, positive for mycobacterium avium complex.On (b)(6) 2018: patient presented with complaints of weakness, fatigue, chronic non-productive cough (approx 6 months) or greater, associated with new night sweats 2-3 times per week and 80 pound weight loss in about 1 year.Patient also described arthralgias which were not limited to one joint or area and were nonspecific.Functional status had declined.Blood cultures collected (b)(6) 2018.On (b)(6) 2018: patient presented with severe functional decline.Blood cultures final report dated (b)(6) 2018 with organism identified as mycobacterium chimaera.Differential diagnosis: suspected disseminated m.Chimaera associated with prior mvr in 2016.

• Brand Name: STOCKERT HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH/LIVANOVA USA, INC.; arvada CO
• MDR Report Key: 8325289
• MDR Text Key: 135906758
• Report Number: MW5083861
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-85
• Is the Reporter a Health Professional?: 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): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 80