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

Model Number 16-02-80

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater/cooler 16-02-80 is not released in the us, but it is a variant of the heater/cooler 16-02-85, which is released in the us ((b)(4)).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 that the sorin heater/cooler system 3t was tested positive for mycobacteria.There was no patient involvement.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 the sorin heater/cooler system 3t was tested positive for mycobacteria.There was no patient involvement.

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).(b)(4).Sorin group (b)(4) received a report that the sorin heater-cooler system 3t system tested positive for mycobacteria.There was no report of any patient involvement.A sorin group service technician was dispatched to the facility to investigate the device.A visual inspection of the outer and inner parts of the heater-cooler unit ((b)(4)) revealed minor residuals and biofilm in several locations including the pumps and water circuits.Based on these findings, 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.The customer has expressed no intention of sending the unit to sorin group (b)(4) for disinfection.The unit has been returned to service.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.

• Brand Name: SORIN HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS, PRODUCT CODE: DWC
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5150404
• MDR Text Key: 28650832
• Report Number: 9611109-2015-00460
• 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
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2007
• 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