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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/13/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There is no known patient involvement.The event date provided was taken from the user report.It is unknown what this date refers to, as this is a request regarding device information in general and does not appear to be related to a specific case or event.No device information has been provided, so the model, serial and udi numbers are unknown.This information will be provided in a supplemental report if and when made available.Facility and initial reporter information was not provided in the user report.This information will be provided in a supplemental report if and when made available.As the model number is unknown, the 510(k) number could not be determined.Two heater-cooler model numbers (16-02-82 and 16-02-85) are distributed in the usa.The 510(k) number is k052601.Additional model numbers (16-02-80, 16-02-83 and 16-02-95) are not distributed in the usa, but are similar to heater-cooler 16-02-85.As the serial number was not provided, a manufacture date could not be determined.This information will be provided in a supplemental report if and when made available.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.It is unknown where this report originated from.This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a user medwatch report (mw5062977) on (b)(6) 2016, stating that the customer has made attempts to contact livanova (formerly sorin group) regarding recommendations for microbiological sampling of the sorin heater-cooler system 3t and remedy to the risk posed by the use of the device.This was done in response to the release of updated ifus for cleaning and maintenance of the heater-cooler devices due to concerns of ntm outbreak risk.The customer noted that the device has a "dead leg" that increases the risk of contamination due to stagnant water.There is no known patient involvement.This is not a complaint about a specific unit, case or patient, but rather a general request from an unknown customer regarding recommendations and information from sorin group (b)(4).As no device information or contact information for the facility or for the initial reporter was provided in the user medwatch report, sorin group (b)(4) is unable to perform any follow-up with the customer regarding this event at this time.Past communication with the fda for different reports has confirmed that any missing or redacted information was removed from the user report at the request of the submitter, and no new information would be provided.The fda suggested performing due diligence to ensure that there is no additional information regarding this event contained in an already existing complaint.A review of existing complaints did not identify any event that matched the description provided in the user report.No further investigation is possible.In the event of receipt of new information, a supplemental report will be provided.In (b)(6) and (b)(6) 2015, fsca (b)(4) was sent out to inform our customers about the updated instructions for use regarding water management and disinfection procedure.

Event Description

Sorin group (b)(4) received a user medwatch report (mw5062977) on (b)(6) 2016, stating that the customer has made attempts to contact livanova (formerly sorin group) regarding recommendations for microbiological sampling of the sorin heater-cooler system 3t and remedy to the risk posed by the use of the device.This was done in response to the release of updated ifus for cleaning and maintenance of the heater-cooler devices due to concerns of ntm outbreak risk.The customer noted that the device has a "dead leg" that increases the risk of contamination due to stagnant water.There is no known patient involvement.

• 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: 5867313
• MDR Text Key: 51876453
• Report Number: 9611109-2016-00505
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Date Manufacturer Received: 07/11/2016
• 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