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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 04/24/2014

Event Type  Injury  

Manufacturer Narrative

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.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6) italy.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a male patient undergoing a mitral valve plastic surgery on (b)(6) 2014 was found to be infected by mycobacterium chimaera.A heater-cooler 3t was used in this surgery.

Manufacturer Narrative

No detailed documentation on the clinical course of the patient was shared with livanova.Livanova initiated an investigation and contacted hospital legal counsel to retrieve additional information of the case including the serial number of device in use at the time of surgery and cleaning/disinfection procedure on heater cooler 3t devices adopted by hospital.However, follow-up attempts made were unresponsive and no further details were communicated.No dhr and shr could be performed accordingly.No device, between the ones in use at the hospital, was upgraded with vacuum and sealing kit at the time of the surgery.A complaints database review identified no device contamination complaints received from this hospital in the year of the surgery (2014).Through follow-up communication under a previous infection complaint that occurred at this same facility, hospital communicated that: the device was cleaned in accordance with the instructions for use valid at the time of the intervention.The fan of the device was oriented away from the surgical field single-patient heated mattresses were sometimes used in the past and reportedly the instructions for use were always followed.Microbial sampling and testing were conducted.Results have not been shared with livanova and there is no evidence that the devices were found to be contaminated.The washing and disinfection mechanisms have always occurred in accordance with the manufacturer's instructions, as documented by the registers of the operating department.The protocols were modified in 2015, in full application of the contents of field safety notice of june 2015.They were then confirmed following the second field safety notice of november 2016.Until 2016, the water destined for the heater coolers was treated with a disinfectant indicated by the manufacturer; since 2016 a pal filter was used on the terminal dedicated to the heater coolers for filling device tanks and replaced according to the periodicity indicated by the manufacturer.The sampling and testing of the water sources were not carried out at the customer site because they were not required by the regulations of the time.Reportedly the customer observed the national survey on the incidence of mycobacterium chimaera prosthetic infections associated with the use of heat coolers in cardiac surgery, the field safety notice issued by livanova and ecdc guidelines.Since october 2009 the following measures were taken: immediate adoption of the maintenance and disinfection procedure, in compliance with the manufacturer's instructions.Following the first notice, salus hospital proceeded to apply the new disinfection methods, contained in the notice itself and in the new edition of the instruction for use in addition, in september 2015 the customer: increased the frequency of disinfections from biweekly to weekly (as indicated by livanova).Positioned the machine as far as possible from the operating field and not oriented directly towards the operating field applied daily replacement of the water in the device tanks.Therefore, it is very likely that above measures were applied at the time of surgery (2014).Based on available data, a causal relationship between livanova device and reported event could not be established.Livanova has implemented a strategy to progressively decrease the probability of bacteria growth in the hc device by applying multiple measures implemented over the past few years and a field safety notice for disinfection and cleaning of heater-cooler devices was distributed under z number z-2076/2081-2015.Livanova will keep monitoring the market.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16435414
• MDR Text Key: 310142978
• Report Number: 9611109-2023-00085
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male