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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 Wound Dehiscence (1154); Bacterial Infection (1735)
Event Date 06/02/2017
Event Type  Injury  
Manufacturer Narrative

Patient weight was not provided. Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(4). This medwatch report is being filed on behalf of livanova (b)(4). Through follow-up communication with the customer, livanova (b)(4) learned that the device has not been tested for contamination. The customer reported that the device has been removed from service but was placed inside the operation room during use with the fan exhaust directed away from the patient field. No further information has been provided. 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.

 
Event Description

Livanova (b)(4) received a report that a patient (initials (b)(6)) has been diagnosed with a mycobacterium chimaera infection. The hospital received the positive test results from the (b)(6) department of health lab on june 2, 2017, confirming the infection. The patient underwent coronary bypass surgery on (b)(6) 2016 and came back on (b)(6) 2017 with wound dehiscense. The patient is currently being treated for surgical site infection and will reportedly be on antibiotics for several months. On june 28, 2017, livanova (b)(4) received a user medwatch report (mw5070434) related to this issue. The report stated that the patient is being treated by infectious disease as an outpatient and that the wound infection is superficial and did not involve the bone.

 
Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). Through follow-up communication, livanova (b)(4) learned that the unit had been sent off-site to comprehensive care services. The device disposition was requested and comprehensive care services confirmed that the unit is sequestered and in their possession. As the device is not available for investigation, an evaluation could not be performed. Corrective actions are in progress for this issue.

 
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Brand NameHEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 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 Key6690186
MDR Text Key79175104
Report Number9611109-2017-00515
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,Followup
Report Date 10/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2017
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2011
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: 07/06/2017 Patient Sequence Number: 1
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