MAUDE Adverse Event Report: SORIN GROUP, USA SORIN (LIVONOVA) GROUP, USA; HEATER COOLER SYSTEM 3T

Model Number 3T

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Type  Other  

Event Description

Bacteria can contaminate the sorin heater cooler units used in conjunction with cardiopulmonary bypass machines.Water samples were taken as per the (b)(6) advisory alert.As per the (b)(6) advisory - this is being reported to the fda watch and the manufacturer.

• Brand Name: SORIN (LIVONOVA) GROUP, USA
• Type of Device: HEATER COOLER SYSTEM 3T
• Manufacturer (Section D): SORIN GROUP, USA; 14401 w 6th way ; arvada CO 80004
• MDR Report Key: 5719944
• MDR Text Key: 47245223
• Report Number: 5719944
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3T
• Device Catalogue Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1