MAUDE Adverse Event Report: LIVANOVA/SORIN SORIN 3T HEATER COOLER UNIT

Device Problems Device Reprocessing Problem (1091); Contamination (1120); Infusion or Flow Problem (2964)

Patient Problem Bacterial Infection (1735)

Event Date 02/16/2016

Event Type  Injury  

Event Description

During routine culturing of our sorin 3t heater cooler unit, we found mycobacterium mucogenicum, recovered from a hcu and the filtered water source used for cleaning and filling of the hcu.After the company field notice last year, we reviewed our current practices to ensure we were aligned with manufacturer recommendations and (b)(6)guidelines.At that time, we cultured all 4 machines and did not recover ntm.In (b)(6) we changed our water source to help with workflow around routine maintenance and the ntm was identified 2 months after implementing our new water source.After receiving these results we switched our water source to sterile water pending remediation to our filtered tap water source and are awaiting follow up culture results to ensure the water source is free of ntm.

Event Description

Add'l to medwatch report filed on 02/26/2016 regarding sorin heater cooler 3t devices.Our biomedical team did a visual inspection of all four of our devices by removing side panels and identified an area of tubing where stagnant water could be caught and backflow into the hcu water reservoir.This info was communicated with sorin who agreed to come out and replace the internal tubing on the machines and plug the tubing to stop any backflow at a cost to our facility.We are currently waiting for approval of a purchased order to schedule this process with sorin.They also recommended a descaling procedure to be performed on the machines with a chemical called neodisher.They asked that we procure this chemical for their rep to perform the descaling procedure at our facility.Upon researching the chemical and finding it to be incredibly corrosive, we opted to not have this process performed on our machines.Most communication with sorin has been verbal conversation.

Event Description

Add'l info received on june 21, 2016 from reporter for mw5060647.Submitting this report as f/u to previous medwatch reports filed on our sorin heater cooler units.Routine sampling of one unit grew extremely high colony counts of pseudomonas putida from the left valve of one hcu and extremely high colony counts of ralstonia picketti from the left valve of another.Cultures were from (b)(6).Also wanted to note in f/u to our last report that when sorin came out to replace tubing and disinfect machines, observers noted that they did not follow their own ifu's during the cleaning/disinfection process.

• Brand Name: SORIN 3T HEATER COOLER UNIT
• Type of Device: HEATER COOLER UNIT
• Manufacturer (Section D): LIVANOVA/SORIN
• MDR Report Key: 5471193
• MDR Text Key: 39427751
• Report Number: MW5060647
• Device Sequence Number: 0
• 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,Followup,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Required Intervention