MAUDE Adverse Event Report: LIVANOVA USA, STOKERT 3T HEATER COOLER

Catalog Number 16-02-85

Device Problem Temperature Problem (3022)

Patient Problems Unspecified Infection (1930); Infection, Indirect (2245)

Event Date 05/09/2015

Event Type  Injury  

Event Description

A (b)(6) pt had heart valve replacement surgery on (b)(6) 2019.On (b)(6) 2019, pt was admitted with a diagnosis of mycobacterium avium intracellulare complex.On (b)(6) 2019, the diagnosis was changed to mycobacterium chimaera after a specialized lab was able to further differentiate this mycobacterium species.Pt was transferred to another facility for specialized treatment of this condition.

• Brand Name: STOKERT 3T HEATER COOLER
• Type of Device: STOKERT 3T HEATER COOLER
• Manufacturer (Section D): LIVANOVA USA, ; houston TX
• MDR Report Key: 8560043
• MDR Text Key: 143536568
• Report Number: 8560043
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2019,04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-85
• 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: 04/18/2019
• Distributor Facility Aware Date: 04/11/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2019
• 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; Life Threatening; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 69