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

Model Number 16-02-80

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Insufficiency (1715); Thrombus (2101)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Serial number is unknown.This information will be provided in a supplemental report if made available.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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).Through follow-up communication with the customer livanova (b)(4) learned that the heater-cooler system 3t was positioned inside the operation theatre approximately 2 meters away from the operation table.In addition, it was reported that the heater-cooler was cleaned according to the instructions for use.The customer does not know which heater-cooler system 3t was used during the procedure.It was possible to confirm the reported patient infection on the replaced valve but the species of the contamination could not be identified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device was not returned.

Event Description

Livanova (b)(4) received a report that a patient who underwent a aortic valve replacement on (b)(6) 2016 got infected with some species of mycobacterium.It was reported that a heater-cooler system 3t was used during procedure.The patient returned to the hospital on (b)(6) 2017 and an aortic dysfunction was identified.An endocarditis could not be confirmed but a thrombus was supposed.Therefore an anticoagulant was provided.The patient returned to the hospital once more on (b)(6) 2017 for an additional valve replacement.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7220930
• MDR Text Key: 98277620
• Report Number: 9611109-2018-00072
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• 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?: No
• Date Manufacturer Received: 12/29/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 72 YR