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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 16-02-82
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 12/28/2015
Event Type  Death  
Manufacturer Narrative
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). A review of complaints database revealed no previous complaints from this hospital associated to the contamination of this specific device. Livanova initiated an investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Event occurred in 2015 thus no possible to understand if device was contaminated at the time of the surgery.
 
Event Description
Livanova (b)(4) received a report that a male patient underwent a cardiac surgery for cabg (single vessel) and mitral valve repair on (b)(6) 2015 and a heater-cooler 3t system was used. The patient showed signs of infection beginning in (b)(6) 2019 and continued to experience symptoms throughout 2019. He was diagnosed with mycobacterium chimaera infection in (b)(6) 2019 and treated with courses of antibiotics. Reportedly, he was unable to undergo a second surgery and passed away on (b)(6) 2021.
 
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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 Key12312382
MDR Text Key266177387
Report Number9611109-2021-00445
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
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-02-82
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 Received09/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2012
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: 08/12/2021 Patient Sequence Number: 1
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