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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); Pain (1994); Weight Changes (2607)
Event Date 08/07/2017
Event Type  Injury  
Manufacturer Narrative

The model and serial number are unknown. This information will be provided in a supplemental report if made available. Initial reporter: the hospital where the surgery took place 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. It is unknown where the incident occurred. This medwatch report is being filed on behalf of livanova (b)(4). The letter from the customer did not indicate a serial number or hospital information. It is unknown if the involved device has been found to be contaminated, or if the reported infection is related to the use of the heater-cooler. Due to ongoing litigation, no further follow-up can be performed at this time. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device availability is unknown.

 
Event Description

Livanova (b)(4) received a letter from a patient who underwent a vessel coronary artery bypass surgery on (b)(6) 2013 and reportedly became infected with mycobacterium chimaera. It was reported that a heater-cooler system 3t was used during the procedure. The patient reported to be feeling fatigue, muscle and join pain, and weight loss. The report indicated that treatment is in progress.

 
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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 Key6895900
MDR Text Key87446493
Report Number9611109-2017-00756
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 OTHER
Remedial Action Other
Type of Report Initial
Report Date 09/26/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2017
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2017
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: 09/26/2017 Patient Sequence Number: 1
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