MAUDE Adverse Event Report: STOCKERT SORIN LIVA NOVA 3T HEATER/COOLER HCD; CONTROLLER TEMPERATURE

Model Number MCG-1000(I)

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 08/19/2017

Event Type  malfunction  

Event Description

Cabg and valve replacement surgery performed.During procedure, stockert livanova 3t hcd (heater/cooler device) was used.Placement, cleaning, and use of the machine was followed per cdc guidelines.Specimen cultures obtained during the procedure returned positive for m.Chimaera bacterium.The pt has tested negative for m.Chimaera bacterium.The concern is that contaminated air may have been blown onto the pt and/or surgical field despite following recommended placement of the machine.

• Brand Name: LIVA NOVA 3T HEATER/COOLER HCD
• Type of Device: CONTROLLER TEMPERATURE
• Manufacturer (Section D): STOCKERT SORIN
• MDR Report Key: 7002738
• MDR Text Key: 91204844
• Report Number: MW5073126
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCG-1000(I)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 77