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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND HEATER-COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 01/09/2018
Event Type  Death  
Manufacturer Narrative

Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). Two devices (16s13101 and 16s13135) are currently in use at the hospital. Both devices were manufactured in 2012 and upgraded with vacuum and sealing configuration respectively in july 2019 and september 2019. The review of the service history records did not identify any information relevant to the reported event. Complaints database analysis revealed no previous device contamination complaints submitted by this hospital. Livanova requested additional information to the customer and reply is still pending. Based on the current level of information, the infection to the prosthesis is likely associated to the femur surgery in 2017 and a the heater-cooler device was not used for this surgery. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

Livanova received a report that a female patient underwent cardiac surgery in 2014 and an heater-cooler 3t system was used. Reportedly the patient became chronically ill and suffered the resulting hursh and debilitating effects. The patient was also operated on the femur in (b)(6) 2017 as a result of which developed an infection to the prosthesis. The patient then died in (b)(6) 2018 and reportedly sepsis contributed significantly to the outcome.

 
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Brand NameHEATER-COOLER 3T SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11314941
MDR Text Key231409874
Report Number9611109-2021-00063
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK191402
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
Report Date 02/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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 Received02/11/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/11/2021 Patient Sequence Number: 1
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