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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A review of the dhr and of the service history records did not identify any deviations or non-conformities relevant to the reported issue.Through further follow-up communication with the chief perfusionist under previous cases reported from the same hospital, livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry.This is not in alignment with current instruction for use however reportedly the devices are very clean and there is no sign of biofilm.The devices are located inside the operating theatre during use.The device used at the hospital resulted to be contaminated.However, the laboratory tests were conducted in the middle of 2020 thus, the status of device at the time of surgery ((b)(6) 2018) remains unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova received report that a male patient had cardiac surgery on (b)(6) 2018 in which the livanova 3t heater-cooler device was utilized during the procedure.Patient presented signs of infection and started to feel ill.Subsequently he tested positive for mycobacterium chimaera.

Manufacturer Narrative

H10: additional information about patient conditions has been received.In december 2019, the patient underwent a sternal would debridement after a fall left him with a sternal incision.Cultures were taken and evaluated at national jewish hospital, which allegedly showed m chimaera.The patient underwent an additional surgery to remove sternal wires and has undergone multiple courses of antibiotics.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11322335
• MDR Text Key: 239459979
• Report Number: 9611109-2021-00071
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other