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U.S. Department of Health and Human Services

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

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STOCKERT SORIN LIVA NOVA 3T HEATER/COOLER HCD CONTROLLER TEMPERATURE Back to Search Results
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.

 
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Brand NameLIVA NOVA 3T HEATER/COOLER HCD
Type of DeviceCONTROLLER TEMPERATURE
Manufacturer (Section D)
STOCKERT SORIN
MDR Report Key7002738
MDR Text Key91204844
Report NumberMW5073126
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Number of Events Reported1
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
Date FDA Received11/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCG-1000(I)
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/06/2017 Patient Sequence Number: 1
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