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

Model Number 16-02-82

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

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.The 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 event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The facility reported that the hospital had two devices in use on the day of the procedure for the operating room in question.However, it is unknown which of the two devices was used for the procedure.During follow-up communication, the customer reported that both devices tested positive for mycobacterium avium-complex in 2015.This contamination was previously unreported and additional medwatch reports will be filed for the individual units.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

On (b)(6) 2017, livanova (b)(4) received a user medwatch report (mw5072266) stating that a patient was admitted to the hospital in 2017 with a fever of unknown origin after undergoing a thoracic aortic dissection repair in 2016, which involved the use of a heater-cooler system 3t.The patient was reportedly discharged on post-operative day 11 and was re-admitted due to the development of the fever.The patient underwent a mediastinal exploration and drainage of what appeared to be a hematoma.Cultures taken during surgery tested positive for mycobacterium chimaera.

• 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: 7010904
• MDR Text Key: 91435684
• Report Number: 9611109-2017-00903
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• 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; Life Threatening; Other