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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fever (1858)
Event Date 08/31/2017
Event Type  Injury  
Manufacturer Narrative

Patient information was not provided. The 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 event occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The facility reported that the hospital had two devices in use on the day of the procedure for the operating room in question. However, it is unknown which of the two devices was used for the procedure. During follow-up communication, the customer reported that both devices tested positive for mycobacterium avium-complex in 2015. This contamination was previously unreported and additional medwatch reports will be filed for the individual units. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.

 
Event Description

On (b)(6) 2017, livanova (b)(4) received a user medwatch report (mw5072266) stating that a patient was admitted to the hospital in 2017 with a fever of unknown origin after undergoing a thoracic aortic dissection repair in 2016, which involved the use of a heater-cooler system 3t. The patient was reportedly discharged on post-operative day 11 and was re-admitted due to the development of the fever. The patient underwent a mediastinal exploration and drainage of what appeared to be a hematoma. Cultures taken during surgery tested positive for mycobacterium chimaera.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7010904
MDR Text Key91435684
Report Number9611109-2017-00903
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 11/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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?
Event Location No Information
Date Manufacturer Received10/10/2017
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

Patient TREATMENT DATA
Date Received: 11/08/2017 Patient Sequence Number: 1
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