MAUDE Adverse Event Report: SORIN GROUP USA, INC. 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/01/2016

Event Type  malfunction  

Event Description

Device contaminated with mycobacterium chimaera.No known patient infections have been identified.Water samples collected from the heater/cooler unit precleaning, postcleaning and filtered tap water all collected about 3 months ago, all found to be positive for mycobacterium chimaera.Manufacturer response for heater cooler system, 3t (per site reporter): manufacturer has been on site and performed maintenance replacing tubing within the unit.The facility is actively investigating options for securing replacement devices.

• Brand Name: 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; scott light; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 6204956
• MDR Text Key: 63295013
• Report Number: 6204956
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N.A.