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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova deutschland received a medwatch form stating that a (b)(6) years old female patient who underwent an aortic valve replacement in (b)(6) 2015 had blood culture found to be positive to mycobacteria.Reportedly, preexisting characteristics such as hypertension, immunocompromised, lupus, breast cancer may have contributed to the event.
 
Manufacturer Narrative
The serial number of the device was provided to livanova and added to the dedicated section d.4.This unit was manufactured in 2017 while the surgery took place in 2015 thus, the involvement of this specific device can be excluded.
 
Event Description
See initial report.
 
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Brand Name
HEATER-COOLER SYSTEM 3T
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key10274755
MDR Text Key198868160
Report Number1718850-2020-01107
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number16-02-85
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/07/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/15/2020
Supplement Dates Manufacturer Received06/16/2020
Supplement Dates FDA Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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