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

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

Patient Problem Death (1802)

Event Date 07/03/2015

Event Type  Death  

Manufacturer Narrative

The model number and the serial number of the unit were not provided.At the time of the cardiac surgery, the facility ((b)(6)) had three heater-cooler systems.All were model number 16-02-80.The serial numbers for the three units are: (b)(4).(b)(6).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).Device manufacture dates for the three units in use at the time of the initial surgery: (b)(4)- may 2003; (b)(4)- december 2005; (b)(4)- december 2005.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group through follow-up communication with the customer, sorin group (b)(4) learned that the facility ((b)(6)) has no records of which device was used on the patient.The customer stated that all three units in use by the hospital at the time of the surgery in (b)(6) 2014 ((b)(4)) were scrapped and replaced in 2015.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 25, 2016, sorin group (b)(4) received a medsun report (mw5065481) stating that a patient died from a nontuberculous bacteria infection after undergoing an aortic heart valve replacement in (b)(6) 2014.The patient was incorrectly diagnosed with sarcoidosis and was prescribed steroids and methotrexate, which lead to a rapid decline.On (b)(6) 2016, sorin group received a user report from the (b)(6) related to the same case, which contained additional information.The report stated that the patient expired on (b)(6) 2016 from endocarditis caused by mycobacterium chimaera at (b)(6) hospital in (b)(6).The report stated that the original surgery took place at (b)(6).Both reports were issued by a family member of the patient.

Manufacturer Narrative

(b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).(b)(4) has not received any additional information regarding test results or the cleaning procedures for any of the heater-cooler devices in use at the time of the patient surgery.All three units in use at the time of surgery have been scrapped by the facility.The dhr and service history reviews for each device did not identify any deviations or non-conformities relevant to the reported issue.An exact root cause for the contamination was not identified.However, as corrective action for this type of issue, a field safety notice has been released to remind our customers about the importance of adhering to the water management and disinfection procedure outlined in the current instructions for use (ifu).Devices discarded.

• 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6119352
• MDR Text Key: 60619182
• Report Number: 9611109-2016-00770
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• 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