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

Model Number 16-02-85

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

Patient Problems Bacterial Infection (1735); Fatigue (1849); Pain (1994); Weight Changes (2607)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

The model and serial number are unknown.This information will be provided in a supplemental report if made available.Initial reporter: the hospital where the surgery took place 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.It is unknown where the incident occurred.This medwatch report is being filed on behalf of livanova (b)(4).The letter from the customer did not indicate a serial number or hospital information.It is unknown if the involved device has been found to be contaminated, or if the reported infection is related to the use of the heater-cooler.Due to ongoing litigation, no further follow-up can be performed at this time.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device availability is unknown.

Event Description

Livanova (b)(4) received a letter from a patient who underwent a vessel coronary artery bypass surgery on (b)(6) 2013 and reportedly became infected with mycobacterium chimaera.It was reported that a heater-cooler system 3t was used during the procedure.The patient reported to be feeling fatigue, muscle and join pain, and weight loss.The report indicated that treatment is in progress.

• 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: 6895900
• MDR Text Key: 87446493
• Report Number: 9611109-2017-00756
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Date Manufacturer Received: 08/28/2017
• 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): Life Threatening; Other; Required Intervention