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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Death (1802)

Event Date 01/09/2018

Event Type  Death  

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) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Two devices (16s13101 and 16s13135) are currently in use at the hospital.Both devices were manufactured in 2012 and upgraded with vacuum and sealing configuration respectively in july 2019 and september 2019.The review of the service history records did not identify any information relevant to the reported event.Complaints database analysis revealed no previous device contamination complaints submitted by this hospital.Livanova requested additional information to the customer and reply is still pending.Based on the current level of information, the infection to the prosthesis is likely associated to the femur surgery in 2017 and a the heater-cooler device was not used for this surgery.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that a female patient underwent cardiac surgery in 2014 and an heater-cooler 3t system was used.Reportedly the patient became chronically ill and suffered the resulting hursh and debilitating effects.The patient was also operated on the femur in (b)(6) 2017 as a result of which developed an infection to the prosthesis.The patient then died in (b)(6) 2018 and reportedly sepsis contributed significantly to the outcome.

• Brand Name: HEATER-COOLER 3T SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• 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: 11314941
• MDR Text Key: 231409874
• Report Number: 9611109-2021-00063
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• 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: 02/11/2021

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: No Information
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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