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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 UNKNOWN
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 06/01/2019
Event Type  Injury  
Manufacturer Narrative
Patient identifier: patient information was not provided. Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices. The z number is z-2076/2081-2015. Livanova (b)(4) 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 received report that a male patient underwent cardiac surgery on (b)(6) 2019 and an heater-cooler system 3t was used. The serial number of device used during surgery is unknown. The patient showed signs of infection and illness. Reportedly, the patient was subjected to treatment and analysis of an infection in his chest. It was reported that his physicians reasonably concluded an ntm infection, but no ntm testing or results are mentioned. The patient continues to undergo treatment.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key12006576
MDR Text Key257208867
Report Number9611109-2021-00317
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2076/2081-2015

Patient Treatment Data
Date Received: 06/16/2021 Patient Sequence Number: 1
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