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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN 3T HEATER COOLER; DIOPULMONARY BYPASS
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SORIN 3T HEATER COOLER; DIOPULMONARY BYPASS Back to Search Results
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 08/17/2015
Event Type  Injury  
Event Description
The 3t heater cooler device made by sorin (now liva nova) has been implicated in some patient infections after cardiovascular surgery with the bacteria, mycobacterium chimera in (b)(6).Children's hospital (b)(6) received the field notice from sorin in the summer of 2015 and new ifu's were instituted (b)(6) 2015.Per the field notice, facilities were to implement water testing of the device.(b)(6) did perform water testing per the field notice on (b)(6) 2015.(b)(6) has been using the 0.22 micron pall filter recommended in the field notice and ifu's.Infection control and industrial hygiene have met with cardiac perfusion team and biomedical engineering to discuss this issue.Have directed them to follow the field notice and to direct the heater cooler away from the surgical field.Cardiac has purchased all new hoses and gel pads that connect to the heater cooler.We have requested from sorin/liva nova that they come out to replace all the valves and dead legs within the device.They have agreed to do this, but we do not have a timeline in place for this work to be completed.
 
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Brand Name
3T HEATER COOLER
Type of Device
DIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN
arvada CO 80000 4
MDR Report Key5553870
MDR Text Key42303754
Report NumberMW5061531
Device Sequence Number0
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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