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

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided. Model and serial numbers are unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in united states. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received the report mw5093038 from fda medwatch program stating that a patient undergone a cardiac surgery on (b)(6) 2017, was readmitted at the hospital in 2019 with blood samples confirming intracellularly mycobacterium infection. Those samples turned out to be m. Chimaera positive later on. The surgery took place in an unknown hospital in the united states. The heater-cooler system 3t serial number used during surgery is unknown.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9915061
• Report Number: 9611109-2020-00228
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015