MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN 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); Fistula (1862)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

Sorin implemented a field safety notice for disinfection and cleaning of sorin heater-cooler devices.The z number is z-2076/2081-2015.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 (b)(4).Through follow-up communication with the customer, sorin group (b)(4) learned that the involved heater-cooler has been removed from service.The customer stated that the cleaning protocols have been followed and the unit was used within the or during procedures.The contact stated that the unit has not and will not be tested for contamination.The customer reported that the patient is currently undergoing care for the infection, which the facility anticipates will need to be continued for approximately 1 year.On december 29, 2016, sorin group (b)(4) received a loaner request from the facility for the involved device, stating that the unit has been sequestered in compliance with governing entities due to non-tuberculous mycabacteria (ntm) contamination.During follow-up communication with the submitter of the loaner request, it was stated that the unit has been tested.However, additional follow-up communication with the customer confirmed that the device has not been tested for contamination.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

Sorin group (b)(4) received a report that cultures from a patient who underwent a surgery in 2014 tested positive for mycobacterium chimaera.The surgery involved the use of a sorin heater-cooler system 3t.The report stated that the device has not been cultured.On january 6, 2017, sorin group (b)(4) received a user medwatch report (mw5066740) related to this patient.The report stated that the patient had a 137-minute-long open heart surgery on (b)(6) 2014 and developed a sternal wound drainage in 2016.The patient was brought in for surgery and a sternal wound fistula was identified, which was traced to 2 inferior sternal wires.The wires were removed and cultures were taken.Bacterial cultures were negative, however an acid fast bacilli culture identified mycobacterium chimaera.

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 livanova (b)(4).Through further follow-up communication, it was stated that no further information will be released from the facility.Therefore no further investigation is possible.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• 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): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6251862
• MDR Text Key: 64883568
• Report Number: 9611109-2016-00953
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other