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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); Fatigue (1849); Pain (1994); Blurred Vision (2137); Chills (2191); Sweating (2444)
Event Date 01/10/2017
Event Type  Malfunction  
Manufacturer Narrative

Patient identifier was not provided. Patient weight was not provided. The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601). 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). Through follow-up communication livanova (b)(4) learned that the heater-cooler system 3t was not tested if it is contaminated. It was reported that the device was placed inside the operation theatre, far away and with the fan positioned away from the operation table. Further samples were taken from the patient but it was not possible to confirm the infection. A review of the dhr did not identify any deviations or non-conformities relevant to the reported 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) 2017, livanova (b)(4) received a user medwatch report ((b)(4)) which indicates that a patient is potentially infected with mycobacterium chimaera. The patient underwent a coronary artery bypass grafting on (b)(6) 2017 and a heater-cooler system 3t was used during the procedure. In (b)(6) 2017 the patient developed night sweats, fatique, back pain, chills and blurry vision.

 
Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(4). Through follow-up communication livanova (b)(4) learned that the patient was discharged pending of additional cultures, afb+. Additional samples were taken. A review of the shr did not identify any deviations or non-conformities relevant to the reported issue. Since the patient has decided to proceed with an attorney, the hospital will have no more communication with the patient. No further investigation is therefore possible. In the event of receipt of new information, a supplemental report will be provided. Corrective actions are in progress for this issue. Device not returned.

 
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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 Key7063147
MDR Text Key93609202
Report Number9611109-2017-00925
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 01/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2017
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?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/26/2012
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: 11/28/2017 Patient Sequence Number: 1
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