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

Model Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Through literature review, livanova (b)(4) became aware of a case report of a (b)(6) male who was diagnosed with m.Chimaera mediastinitis a year after type a dissection repair (and 3t exposure) and was started on quadruple antimicrobial therapy also due to iris (immune reconstitution inflammatory syndrome).Symptoms presented with a declining of kidney function, pancytopenia, and hypercalcemia which after bone marrow and kidney biopsies were attributed to iris.The patient continued to clinically improve and feel better after 8 months of therapy.

Manufacturer Narrative

Patient information was not provided.Model and serial number is 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 (b)(6), united states.The device serial number used during surgery is unknown.Through follow-up communication with the author of the article, livanova learned that the patient underwent his surgery at (b)(6) medical center in (b)(6) in (b)(6) 2015.Thus, the device was not upgraded with vacuum and sealing kit which was introduced in 2018/2019.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich, germany 80309 ; GM 80309
• MDR Report Key: 12758595
• MDR Text Key: 282639423
• Report Number: 1718850-2021-01217
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2021,11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2021
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male