MAUDE Adverse Event Report: LIVANOVA/ SORIN 3T HEATER-COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problems Device Reprocessing Problem (1091); Contamination (1120); Device Maintenance Issue (1379)

Patient Problem No Code Available (3191)

Event Date 01/13/2016

Event Type  Injury  

Event Description

Livanova (formally sorin) released updated ifus for cleaning and maintenance of their 3t heater-cooler device due to concerns of ntm outbreak risks.The device has been noted to have a "dead leg" from visual inspection that increases the risk of contamination due to stagnant water.Multiple attempts have been completed to get in contact with the mfr to remedy this risk in design, and to get recommendations for microbiologic testing.

• Brand Name: 3T HEATER-COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA/ SORIN
• MDR Report Key: 5744456
• MDR Text Key: 48119642
• Report Number: MW5062977
• Device Sequence Number: 0
• Product Code: DWC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention