MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH 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.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 (b)(6) years old male patient infected with mycobacterium chimaera.He underwent placement of a heartmate ii lvad via median sternotomy with normothermic cardiopulmonary bypass.He required device exchange 4 years later for pump stoppage due to electrical failure, and this was performed via redo-sternotomy with normothermic cardiopulmonary bypass.One year later he presented with a right-sided abdominal wall fluid collection contiguous with the internal driveline tunnel.The fluid was drained percutaneously and acid-fast bacilli were noted on microscopy.Treatment with azithromycin, ethambutol, and rifampin was initiated and mycobacterial culture was positive for m.Chimaera.Debridement and a delayed flap coverage of exposed hardware was performed.Within several weeks of the procedure, the patient developed abdominal wall cellulitis and wound drainage, requiring incision and drainage and treatment with additional broad spectrum antibiotics.He is followed as an outpatient, now 3 months after presenting with the m.Chimaera device-related infection.The date of surgery is between 2011 and 2016 and a heater-cooler 3t device was used.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• 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: 10157656
• MDR Text Key: 198699115
• Report Number: 9611109-2020-00353
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/16/2020

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: 16-02-85
• 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