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 Type  Injury  

Manufacturer Narrative

Patient information was not provided.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 (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).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 learned about a m.Chimaera infection retrospective study conducted in (b)(6).Within the article is stated that 9 patients resulted to be infected with m.Chimaera.This report captures 4 over 9 cases since five (5) of those were already registered in livanova database and already reported under mfr report numbers: 9611109-2015-00525, 9611109-2015-00624, 9611109-2017-00205, 9611109-2017-00279, 9611109-2018-00165.Within the article it is stated that 2 patient recovered and the other 7 are still under treatment.These patients had undergone valve replacement in several hospitals between 2007 and 2015 and presented with endocarditis with or without aortic root abscess or dissemination, deep surgical site infection, spinal osteomyelitis and disseminated disease.Heater-cooler systems 3t , hcu30s and hcu40s were used during the mentioned surgeries (between 2007 and 2015).Thirtyfive (35) heater-cooler systems 3t , six (6) hcu30s and four (4) hcu40s were sampled at several hospital between february and august 2015 and twentyseven (27) 3ts, three(3) hcu40s and four (4) hcu30s were found positive to mycobacteria.Among those, seventeen (17) 3ts, one (1) hcu30 and one (1) hcu40 were positive to m.Chimaera.It is unclear if these sampled devices were including the ones actually used for the above mentioned surgeries.The hospitals where the surgeries took place and the serial numbers of the devices used during the procedures are unknown.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 14401 w. 65th way; arvada 80004 ; GM 80004
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 10157645
• MDR Text Key: 199844278
• Report Number: 9611109-2020-00350
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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: 05/20/2020
• 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): Other