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 Problem Death (1802)

Event Date 04/17/2015

Event Type  Death  

Manufacturer Narrative

The user medwatch report lists the date of death as (b)(6) 2016.However, the description states that the patient died in fall 2016.Follow-up communication with the customer confirmed that the patient died in 2016.The exact date was not available.The user medwatch report lists 3 serial numbers (all (b)(4)).It is unknown which device was used on the patient.(b)(4).Device manufacture date (mm/dd/yyyy): (b)(4)- 12/17/2009; (b)(4)- 04/02/2012; (b)(4)- 11/15/2012.Sorin group deutschland manufactures the sorin heater-cooler system 3t.The incident occurred in st.Paul, minnesota.This medwatch report is being filed on behalf of sorin group deutschland.During follow-up communication with the customer on november 17, 2016, the contact stated that the exact date of death was not provided to her.The patient did not die at regions hospital in st.Paul, mn.The customer believes the patient died some time in 2016.The customer also stated that all three units in use at the facility at the time of the procedure have been removed from service.The contact was not aware of any bacterial testing of the devices and did not know if units were placed inside or outside the operating room during use.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

On october 27, 2016, sorin group (b)(4) received a user medwatch report ((b)(4)) stating that a patient died after being diagnosed with a mycobacterium chimaera infection.The patient underwent a coronary artery bypass graft procedure, aortic valve replacement, and abdominal aortic aneurysm repair in 2015.The procedure involved the user of a sorin heater-cooler system 3t.The patient did well with the surgery and post-operatively.In 2016, the hospital (regions hospital in st.Paul, mn) received a notification that the patient was diagnosed with an m.Chimaera infection and subsequently expired.

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Additional follow-up communication with the customer confirmed that they still do not have any further information available related to the involved device(s) or the patient.No device issue has been alleged or confirmed by the customer.

Manufacturer Narrative

During a complaint review conducted on july 13, 2107, it was discovered that this issue was reported by multiple facilities, as the surgery and death did not occur at the same hospital.In addition to (b)(6) hospital, who was documented on the initial report and follow-up 1, the issue was also reported by (b)(6) hospital (where the death occurred) on user medwatch report mw5066126 and on the manufacturer report 9611109-2016-00887.The manufacturer report 9611109-2016-00887 has now been voided as a duplicate and all details reported by the two facilities are now documented in this report (9611109-2016-00775; see below).Date of death: (b)(6) 2016.Event description as reported by hospital where death occurred: on november 28, 2016, livanova (b)(4) received a user medwatch report (mw5066126) stating that a patient presented with a non-tuberculous mycobacterium infection after undergoing cardiac bypass surgery a year prior at a different facility.The patient died from the complications of the infection.(b)(6).Additional manufacturer narrative regarding information provided by hospital where death occurred: through follow-up communication with the (b)(6), livanova (b)(4) learned that the patient was admitted to the (b)(6) on (b)(6) 2016, where a complicated washout/debridement of the mediastinal infection was performed.The patient died on (b)(6) 2016 at the age of (b)(6).

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• 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: 6123292
• MDR Text Key: 60742150
• Report Number: 9611109-2016-00775
• 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,Followup,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• 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: 07/13/2017
• 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: 66 YR
• Patient Weight: 119