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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2015

Event Type  No Answer Provided  

Manufacturer Narrative

There is no known patient involvement.The user report did not specify an event date.However, follow-up communication with the customer revealed that the first positive test results were received on (b)(6) 2015.This date was selected as the event date.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).Through follow-up communication with the customer, sorin group (b)(4) learned that the heater-cooler tested positive for m.Chelonae on (b)(6) 2015 and for m.Immunogenum on (b)(6) 2016.The customer stated that the unit is used within the operation theatre directed away from the sterile field.The unit is still currently in use.The customer also stated that the water filter has been changed and weekly cleaning has been performed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

On (b)(6) 2016, sorin group (b)(4) received a user medwatch report (mw5065908) stating that the sorin heater-cooler system 3t tested positive for mycobacterium chelonae and mycobacterium immunogenum.The report indicated that the cleaning and disinfection procedure is being followed per the manufacturer's recommendations.There is no known patient involvement.

Manufacturer Narrative

The facility address provided in the initial report, submitted december 23, 2016, was incorrect.The correct facility address is: (b)(6).

• 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; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6202811
• MDR Text Key: 63264613
• Report Number: 9611109-2016-00884
• 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: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: 12/05/2016
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• 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