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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 Problems Bacterial Infection (1735); Death (1802)
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). The serial number of the device used during procedure is unknown as well as the cleaning practise in use at the hospital at the time of the surgery. A complaints database review revealed no device contamination complaints received from this hospital. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

Through literature review livanova became aware of a (b)(6) years old male patient with a disseminated m. Chimaera infection following aortic dissection surgery in 2015. The patient developed an aortic root aneurysm diagnosed by echocardiogram in 2016, requiring redo-sternotomy and a bentall procedure in 2017. Medical history included cachexia and dorsalgia with a work/up revealing vertebral osteomyelitis with an epidural abscess, bone marrow and pulmonary infiltration with fluid collection around the aortic graft. The patient was subjected to antibiotics for one month before the explanation of infected foreign material, mediastinal debridement and aortic reconstruction. Complications included septic shock, respiratory and renal failure, mediastinitis and four distal aortic anastomotic dehiscences from friable tissue and persistent infection. He required wide debridement of infected mediastinal tissues and underwent a delayed vertical rectus abdominis myocutaneous flap closure of the chest. Days later the patient had recurrent active bleeding from his sternum and developed hemorrhagic shock ending with patient death. Within the article it is stated that the hospital used heater/cooler 3t systems.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10688573
MDR Text Key211623994
Report Number9611109-2020-00575
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,LITERATUR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received09/16/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberZ-2076/2081-2015

Patient TREATMENT DATA
Date Received: 10/16/2020 Patient Sequence Number: 1
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