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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problems Abscess (1690); Endocarditis (1834)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Event date.The facility did not provide the event date.This information will be provided in a follow-up report if it becomes available.Pma 510(k).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 (510k#: k052601).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).Sorin group received a report that a patient was diagnosed with mycobacterial prosthetic valve endocarditis and aortic root abscess approximately 10 months after undergoing aortic valve replacement surgery which involved the use of the sorin heater-cooler system 3t.It was also reported that testing performed by the hospital found one of the heater-cooler systems at the facility to be contaminated.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 was diagnosed with mycobacterial prosthetic valve endocarditis and aortic root abscess approximately 10 months after undergoing aortic valve replacement surgery which involved the use of the sorin heater-cooler system 3t.It was also reported that testing performed by the hospital found one of the heater-cooler systems at the facility to be contaminated.

Manufacturer Narrative

Pt gender.Male.Outcome attributed to: death.Event date.(b)(6) 2015.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 deutschland (b)(4) received a report that a patient was diagnosed with mycobacterial prosthetic valve endocarditis and aortic root abscess approximately 10 months after undergoing aortic valve replacement surgery which involved the use of the sorin heater-cooler system 3t.It was also reported that testing performed by the hospital found one of the heater-cooler systems at the facility to be contaminated.Follow-up communication with the customer revealed that the patient died from the mycobacteria infection, but it could not be confirmed that the strain found in the patient was the same as the strain from the contaminated unit.A sorin group service technician was dispatched to the facility to inspect contaminated device and a visual inspection of the outer and inner parts of the heater-cooler unit was performed.The inspection of the sorin heater-cooler system 3t revealed residuals and biofilm in several locations, mainly the lower overflow tubing.Based on the obvious biofilm found in the water circuits of the devices inspected, it was concluded that this issue was the result of the user failing to adhere to the cleaning and disinfection instructions outlined in the ifu.After intensive disinfection cycles, water samples taken from the unit no longer show contamination.As corrective action, fsca 9611109-06/03/15-002-c was released to remind our customers about the importance of adhering to the water management and disinfection procedure.Evaluated on site by sorin service rep.

Manufacturer Narrative

Sorin group (b)(4) received a report that a patient was diagnosed with mycobacterial prosthetic valve endocarditis and aortic root abscess approximately 10 months after undergoing aortic valve replacement surgery which involved the use of the sorin heater-cooler system 3t.It was also reported that testing performed by the hospital found one of the heater-cooler systems at the facility to be contaminated.Follow-up communication with the customer revealed that the patient died from the mycobacteria infection, but it could not be confirmed that the strain found in the patient was the same as the strain from the contaminated unit.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Evaluated on site by sorin service rep.

• 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
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5179019
• MDR Text Key: 29288383
• Report Number: 9611109-2015-00503
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 16-02-80
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2012
• 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): Other