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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND GMBH 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
Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Livanova initiated an investigation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova received a medwatch importer report (b)(4) stating that in (b)(6) 2017, a patient undergone a cardiac surgery and he was recently identified positive to mycobacterium chimaera. A heater-cooler system 3t was used during the surgery. Within the report are stated other information about the patient that may have influenced the outcome of the event: interstitial pulmonary fibrosis diagnosed around 7 years. He presented to clinic with weight gain, peripheral edema, cough and increased dyspnea on exertion. In the past, he has had prolonged carbon silicon exposure.
 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key9737539
MDR Text Key194012505
Report Number9611109-2020-00119
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-85
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 Received03/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/11/2017
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

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