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 Problems Bacterial Infection (1735); Death (1802)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Through literature review livanova became aware of 9 patients deaths.These patients were found positive to mycobacterium abscessus at (b)(6) hospital.Within the article it is stated that the hospital used heater-cooler 3t systems.Reportedly.All patient had extensive preoperative comorbidities and complicated postoperative courses in addition to mycobacterium abscessus infection.For this reason, it is reportedly uncertain if patient deaths were attributable to mycobacterium abscessus data presented in the article were collected between august 2013 and may 2014 and between december 2014 and june 2015.Moreover, within the article it is stated that despite changes of the instruction for use in 2010 recommending filtered tap water, it was found that water changes were performed with unfiltered tap water for the devices in use at the hospital and that the disinfection procedure was not applied according to the ifu.Cultures from biofilms of heater-cooler devices were negative fro m.Abscessus while the culture from biofilm of the faucet used to fill the units was positive to m.Abscessus.Reportedly, on early (b)(6) 2015, the hospital changed the approach and followed the ifu.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• MDR Report Key: 10200060
• MDR Text Key: 196592331
• Report Number: 1718850-2020-01102
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death