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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858); Pneumonia (2011); Sepsis (2067)
Event Date 01/08/2014
Event Type  Injury  
Manufacturer Narrative

Patient information was not provided. The serial number was not provided. This information will be provided in a supplemental report if made available. Customer information was not provided. 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 the united sates. No device malfunction was noted in the user report. It is unknown if any malfunction of the involved device has occurred. The report did not provide any information on the device or other identifying information for the reporting facility. For this reason, no follow-up communication could be conducted. A review of existing complaints was unable to identify an existing complaint that fit the description and dates contained within the medwatch report. No further investigation for this complaint could be performed. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

 
Event Description

On march 26, 2018, livanova (b)(4) received a user medwatch report (mw5075658) indicating that a mycobacterium chimaera infection was identified in a sputum specimen of a patient who underwent open heart surgery where a heater-cooler system 3t was used. The report indicated that the patient received a letter from the hospital in 2016. It was reported that the patient had thoracocentesis roughly three days following the surgery and developed bilateral pneumonia after being discharged. The patient also reportedly had lung complications following the surgery. The patient was admitted to the icu several times in 2017 with sepsis, fever and fatigue. The patient reportedly suffers from a cough and green sputum. The patient is under therapy with symbicort inhaler, lipitor, spronolactone, gabapentin, xanax, requip, nitrostat, eflexor, trazadone, metoprolol, renexa, plavix, protonix, amatriptyline, zanaflex, tramadol, albuterol inhaler, stool softener, senna and aspirin.

 
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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 Key7455091
MDR Text Key106309057
Report Number9611109-2018-00916
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 Other
Type of Report Initial
Report Date 04/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated By Manufacturer? No
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: 04/24/2018 Patient Sequence Number: 1
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