MAUDE Adverse Event Report: SORIN GROUP USA STOCKERT - SORIN 3T HEATER COOLER

Model Number 3T

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Death (1802)

Event Type  Death  

Event Description

The 15 pts have tested positive +afb for an atypical mycobacterium infection.All infections have been surgical site infections.The investigation is still on-going.The common denominator for the cardiac surgeries is the profusion machine.The machine has been cultured and found to have the mycobacterium in the water.The machine was pulled from service (b)(6) 2014.The terumo health exchanger was being used on the machine.(b)(6) has increased the frequency of the vendor's recommendation for disinfection from every two weeks to weekly.Out of the 15 pts that were infected, 4 have expired.The infections were thought to be a contributing factor, yet all pts had major, underlying existing and significant medical conditions.Several pts in the hosp presented with post-operative wound infections caused by an unusual organism, atypical mycobacterium.It has been determined that a total of 15 pts who had surgery were infected.The investigation is still on-going and the exact etiology is still unk.A common factor for many of the pts infected is the sorin profusion machine.

• Brand Name: STOCKERT - SORIN 3T HEATER COOLER
• Type of Device: 3T HEATER COOLER
• Manufacturer (Section D): SORIN GROUP USA; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 3984530
• MDR Text Key: 21879548
• Report Number: 3984530
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3T
• Device Catalogue Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/05/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 06/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR