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

Model Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 03/26/2019

Event Type  Death  

Manufacturer Narrative

D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.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.H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.This report was due on november 24, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Complainant alleges through their counsel a mycobacterium chimaera infection following a cardiac surgery (placement of a left ventricular assistive device) carried out on (b)(6) 2019, in which a heater-cooler system 3t was used.In (b)(6) 2023 the patient developed first symptoms of the infection: he began losing weight, feeling fatigued and weak, and developed a cough.In (b)(6) of 2023 he developed a large cyst at the bottom of his surgical scar, which was infected.Cultures from patient¿s tissue taken on (b)(6) 2023 returned a positive result confirming a mycobacterium chimaera infection on (b)(6) 2023.Patient was diagnosed with disseminated mycobacterium chimaera, which had spread to his brain and eyes.Patient died on (b)(6) 2023.Based on current status of the investigation the alleged device issue was not confirmed yet.

Event Description

See initial report.

Manufacturer Narrative

H10: a device history record (dhr) review could not be performed since possible serial number involved was not provided.Since no further information has been made available, no further investigation is possible.Source of patient contamination remains unknown and a direct relationship between the reported adverse event and the device could not be established.

• 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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18310148
• MDR Text Key: 330278040
• Report Number: 9611109-2023-00635
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/04/2024
• 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 Outcome(s): Death
• Patient Sex: Male