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

Model Number 16-02-80

Device Problems Failure to Disinfect (1175); Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 08/22/2011

Event Type  Injury  

Manufacturer Narrative

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).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).Sorin group (b)(4) received a report regarding a patient that underwent heart valve replacement in 2011.The hospital reported that in 2013, the patient was treated for endocarditis with mycobacteria chimaera.The patient required re-surgery and antibiotic therapy.In 2014, the hospital identified mycobacteria chimaera in the tanks of the sorin heater-cooler system 3t and in the air exhaust from the unit.Sorin group (b)(4) has received further information about the patient status from the customer.The affected patient is no longer being treated with antibiotics.Although there was only one report of patient injury, the facility reported three serial numbers because it is unknown which of the 3 units was involved in the procedure.The facility does not track which serial number is used for a given case.The serial number indicated in this report (b)(4) was one of three reported serial numbers.For information on the other 2 serial numbers, please reference report numbers 9611109-2015-00083 and 9611109-2016-00034.The heater-cooler was returned to sorin group deutschland for deep disinfection.An inspection of the outer and inner parts of the returned heater-cooler system (b)(4) revealed residuals and biofilm in several locations including the tubing, pumps and floats of the cardioplegia and patient circuit tanks.Water samples were taken and analyzed by an external accredited laboratory.Mycobacteria chimaera were found within the water samples.A review of the dhr did not identify any concessions, deviations or non-conformities relevant to the reported failure.Based on the visual inspection and biofilm in the water circuits of the devices inspected, it was concluded that the users have not followed the cleaning and disinfection instructions according to the ifu.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.On january 13, 2016, a retrospective evaluation identified that the information on this serial number has not yet been provided in a medwatch report.

Event Description

Sorin group (b)(4) received a report regarding a patient that underwent heart valve replacement in 2011.The hospital reported that in 2013, the patient was treated for endocarditis with mycobacteria chimaera.The patient required re-surgery and antibiotic therapy.In 2014, the hospital identified mycobacteria chimaera in the tanks of the sorin heater-cooler system 3t and in the air exhaust from the unit.

• 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 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5481940
• MDR Text Key: 39734988
• Report Number: 9611109-2016-00035
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2010
• 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
• Patient Age: 76 YR