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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 Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative

Patient information was not provided. Serial number is unknown. This information will be provided in a supplemental report if made available. Livanova (b)(4) did not receive any information about submitter identity. 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. Recall number: 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) received a user medwatch report mw5080026 stating that a patient was found to be infected by mai / mac. However no further information about customer and involved product were made available in the medwatch. With the information available no further investigation can be performed and no root cause identified. Corrective actions are in progress for this issue. 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) 2018, livanova (b)(4) received a user medwatch report (mw5080026) stating that a patient who underwent a coronary artery bypass and mitral valve replacement in 2008 and a re-do sternotomy and mitral valve replacement in 2015 was found to have a positive blood culture for mal/mac. It was further stated that the patient suffered intermittent fevers and fatigue for several months in 2018.

 
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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 Key8040767
MDR Text Key126219476
Report Number9611109-2018-01315
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
PMA/PMN NumberK052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Remedial Action Notification
Type of Report Initial
Report Date 11/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2018
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/08/2018
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: 11/06/2018 Patient Sequence Number: 1
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