MAUDE Adverse Event Report: SORIN SORIN 3T HEATER COOLER

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 11/11/2015

Event Type  malfunction  

Event Description

(b)(6) uses sorin 3t heater coolers during cardiac bypass procedures at (b)(6).On (b)(6) 2015 received field safety notice for the heater-cooler system 3t disinfection process, usa from the sorin group, medical technology.Sorin theater cooler machines are cleaned per manufacturer's recommendations.Biotest labs (the lab recommended for sending surveillance cultures to by sorin) notified us of some growth on samples sent from (b)(6) 2015.At our request, biotest forwarded these specimens to (b)(4) who performed genetic testing to determine if any of the organisms isolated are mycobacteria.Four of the 5 sorin t machines had specimens identified with mycobacterium avium.Sorin 3t heater cooler model# 16-02-85; s/n (b)(4), manuf.Date 08/09; s/n (b)(4), manf.Date 05/11; s/n (b)(4), manuf.Date 12/11; s/n (b)(4) manuf.Date 08/12.

• Brand Name: SORIN 3T HEATER COOLER
• Type of Device: HEATER COOLER
• Manufacturer (Section D): SORIN
• MDR Report Key: 5454978
• MDR Text Key: 38863167
• Report Number: MW5060415
• Device Sequence Number: 4
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 08/01/2012
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other