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

Model Number 16-02-82 (OR) 16-02-81

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Foreign Body In Patient (2687)

Event Date 12/01/2017

Event Type  Death  

Manufacturer Narrative

Patient related information is not provided.Part number and serial number of the device in question not provided.Date of manufacturing unavailable as the serial number is unknown.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of the heater-cooler system 3t devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).During a preliminary communication, livanova (b)(4) learnt that the hospital was continuing to use the affected unit.A replacement unit was ordered and is awaited for delivery.The hospital follows all instructions emphasised by the manufacturer in the instructions for use, in maintaining and cleaning the heater-cooler 3t.Additionally, the hospital declared that they have also implemented safety measures to further minimize risk to the patients while using the heater-cooler system 3t, although no further details were provided.The device was not tracked during the time of surgery thereby the serial number not being available.The unit has been upgraded with the vacuum system onsite.The investigation is ongoing.Corrective actions are in progress for this issue.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 (b)(4) received a report that on december 2017, a patient was confirmed to be tested positive for m.Chimaera post cardiovascular surgery in (b)(6) 2016.The heater-cooler 3t was used during the cardiovascular surgery.Patient is recovering in the hospital.

Event Description

See initial report.

Manufacturer Narrative

Through media monitoring livanova became aware of a newspaper article mentioning ten (10) confirmed cases of patient infections in (b)(6).All 10 infections in (b)(6) are captured in livanova complaints database and the article has been evaluated for missing additional information for each specific case.Within the article it is specified that 8 patients died and that the other 2 are alive.Based on details such as surgery date, livanova has been able to trace some information to this specific event.Within the article it is stated that the patient underwent cardiac surgery in (b)(6) 2016 as already reported in the initial report.In addition, the article states that the patient died as a result of m.Chimaera infection in (b)(6) 2018, two months after doctors confirmed he'd been infected.By then, it had spread to his bone marrow and his brain.The patient was (b)(6) years old.Thus, the event outcome for this case has been updated as death.No device was upgraded with vacuum and sealing kit at the time of 2016 surgery.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7185297
• MDR Text Key: 97057204
• Report Number: 9611109-2018-00036
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82 (OR) 16-02-81
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening