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U.S. Department of Health and Human Services

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

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LIVANOVA/SORIN 3T HEATER COOLER MACHINE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Contamination (1120)
Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Event Date 03/03/2017
Event Type  Injury  
Event Description

Pt had cabg x 4 on (b)(6) 2016 and came back on (b)(6) 2017 with wound dehiscence. Sorin 3t heater cooler device (livanova) utilized during surgery. Pt confirmed positive for m chimaera on results received from (b)(6) lab on (b)(6) 2017. Machine returned to livanova. Case reported to livanova as well. Pt being treated by infectious disease as outpatient for wound infection. Wound is superficial and according to id did not involve the bone.

 
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Brand Name3T HEATER COOLER MACHINE
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA/SORIN
munich, de
MDR Report Key6646676
MDR Text Key77837853
Report NumberMW5070434
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Device Returned To Manufacturer
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: 06/14/2017 Patient Sequence Number: 1
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