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

Model Number 16-02-85

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 01/20/2016

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.The serial number cannot be determined because the facility did not track which unit was used for a given procedure at the time that this complaint was received.Mfg date: the serial number could not be determined, so the manufacture date is unknown.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(4).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that a patient presented with non-tuberculosis mycbacterium infection potentially related to a sorin heater-cooler system 3t.At the time of the patient's open heart surgery, the facility did not track which unit was used for a given case, so the involved unit cannot be determined.The facility has taken samples of the units for culture but the results are not yet known.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 a patient presented with (b)(6) mycbacterium infection potentially related to a sorin heater-cooler system 3t.At the time of the patient's open heart surgery, the facility did not track which unit was used for a given case, so the involved unit cannot be determined.The facility has taken samples of the units for culture but the results are not yet known.

Manufacturer Narrative

Pt initials: (b)(6).Age: (b)(6) years patient weight: (b)(6).Death date of death (mm/dd/yyyy): (b)(6) 2016.Serial number: (b)(4).Type of reportable event: death.Device manufacture date (m/dd/yyyy): (b)(4) 11/19/2010.(b)(4) 11/19/2010.(b)(4) 11/19/2010.(b)(4) 12/21/2011.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).On january 28, 2016, sorin group received a report that a patient at ui heart and vascular presented with a (b)(6) mycobacterium infection potentially related to a sorin heater-cooler system 3t.Sorin group (b)(4) was informed that, at the time of the patient's open heart surgery, the facility did not track which unit was used for a given case, so the involved unit was not known.At the time of the complaint, machine samples had been taken but the results were not yet known.On february 10, 2016, sorin group received a user medwatch report ((b)(4), which contained information about the patient and involved units that was not included in the initial report.The user report stated that the patient was diagnosed with a disseminated mycobacterium chimaera infection four years following an aortic valve procedure that involved the use of a sorin heater-cooler system 3t.Four serial numbers (b)(4) were also listed in the user report.The initial report, submitted (b)(6) 2016, documented the information reported in the original complaint.However, the initial report inadvertently neglected to specify the procedure type, specific infection type and the four serial numbers documented in user report (b)(4).Follow-up communication with the customer in may 3, 2016 confirmed that the units were originally placed inside the operating room and were briefly quarantined and samples were taken following the event.However, at that time, the facility had already returned the units to service outside the operating room.The customer also reported that the cleaning and disinfection procedure outlined in the instructions for use (ifu) had always been followed.On may 19, 2016, the customer reported that the samples taken from each of the four units all came back positive for mycobacterium chimaera.On august 23, 2016, sorin group learned of a legal complaint alleging that a patient (initials (b)(6)) had undergone a heart-valve replacement procedure at (b)(6) on (b)(6) 2012.The procedure allegedly involved the use of a sorin heater-cooler system 3t.In (b)(6) 2014, the patient reportedly presented with muscle pain, fatigue, night sweats, persistent fever and a dry cough.According to the filing, the patient was reportedly diagnosed with a mycobacterium chimaera infection in (b)(6) 2014 and was started on antibiotics.The legal complaint alleges that monthly blood cultures taken from the patient from the time of diagnosis through (b)(6) 2015 showed the presence of mycobacterium chimaera.According to the legal complaint, the patient was admitted to the hospital on (b)(6) 2016 and discontinued all antibiotics and substantial medical intervention.The legal complaint alleges that the patient passed away on (b)(6) 2016, with cause of death identified as disseminated mycobacterium avium intracellular complex infection.On september 6, 2016, sorin group received a follow-up user medwatch report (b)(4).The follow-up report stated that the patient identified in (b)(4) had passed away on (b)(6) 2016 due to the m.Chimaera infection.Through analysis of this report, sorin group believes that the legal complaint received on august 23, 2016 is related to the patient documented in user medwatch reports (b)(6).A review of the dhrs for all four devices did not identify any deviations or non-conformities relevant to the reported issue.The investigation is still on-going.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

In the previously filed supplemental report (follow-up 1, submitted september 16, 2016), fields were inadvertently left blank.This report is being submitted to correct this error.Sorin implemented a field safety notice for disinfection and cleaning of sorin heater-cooler devices.The z number is z-2076/2081-2015.

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).Several attempts were made to obtain additional information regarding the contamination status of the devices in use at the facility.However, no further information has been provided.It is unlikely that more information will be provided due to on-going litigation.Corrective actions are in progress for this type of 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; muncih 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5459169
• MDR Text Key: 38964101
• Report Number: 9611109-2016-00062
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• 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
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other