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 Problem Bacterial Infection (1735)

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.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 an unknown city, most likely 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 a (b)(6) year old patient who underwent cardiac surgery in (b)(6) 2014.The hospital where the surgery took place is unknown.Sixteen (16) months after the surgery he presented night sweats and severe muscle aches with concomitant pain in his knees and hands.Evaluation showed mild anemia and elevated liver function tests but there was no clear diagnosis and was treated symptomatically.He experienced weight loss and malaise.Twenty-eight (28) months after the surgery, m.Chimaera infection was detected from urine and liver biopsy and (b)(6) was diagnosed.Ophtalmology examination demonstrated choroid lesions consistent with mycobacterial infection.The patient was treated with antibiotics therapy with resolution of his night sweats and weight loss noted.Subsequent mycobacterial blood cultures were sterile.After six (6) months of treatment the patient developed high creatinine and bronzing of his skin.The patient was referred to (b)(6) clinic in (b)(6) for a second opinion and further management.Tests showed typical postoperative changes.However, due to concern regarding chimaera infection, the patient underwent another surgery and tissue tested positive for chimaera.The patient was discharged home on a 4-drug antimycobacterial regimen with plans for at least twelve (12) months of treatment.Four (4) months after the second surgery, the patient improved, his weight increased and returned back to work.

• 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: 10199504
• MDR Text Key: 202872632
• Report Number: 1718850-2020-01100
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• 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
• Distributor Facility Aware Date: 05/28/2020
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other