MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN 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); Death (1802)

Event Date 03/29/2016

Event Type  Death  

Manufacturer Narrative

Patient identifier was not disclosed.Patient weight was stated as unknown in the user report.The event date in the user medwatch report was listed as the date of the procedure ((b)(6) 2011).However, we have selected the event date to be the day when the patient presented with symptoms ((b)(6) 2916).The serial number of the involved device is unknown.This information will be provided in a supplemental report if and when 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 and when made available.(b)(4).Through follow-up communication with the customer, sorin group deutschland learned that the units in use at the facility at the time of the surgery have been tested.However, the test results have not been provided.The contact stated that the units are not tested on a regular basis.The customer reported that one new device has been obtained.However, all of the units are still in use and are operated within the or.Circumstances surrounding the patient's death are unknown at this time.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

On january 6, 2017, sorin group (b)(4) received a user medwatch report (b)(4) stating that a patient presented with symptoms of infection on (b)(6) 2016 after undergoing a coronary artery bypass grafting procedure on (b)(6) 2011 that included the use of a sorin heater-cooler system 3t.The symptoms included general malaise, weakness, fatigue and poor oral intake.Blood cultures were taken on (b)(6) 2016 and tested positive for mycobacterium avium complex.The report stated that additional testing of blood cultures is being conducted.The patient was reported to have expired 5 months after presenting with symptoms, on (b)(6) 2016.The exact cause of death was not reported.

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6300480
• MDR Text Key: 66479085
• Report Number: 9611109-2017-00018
• 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: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2017
• 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): Death
• Patient Age: 48 YR