MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-82

Device Problem Microbial Contamination of Device (2303)

Patient Problem Death (1802)

Event Date 03/25/2015

Event Type  Death  

Manufacturer Narrative

Death date was not provided.This information will be provided in a supplemental report if made available.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) 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 with the customer livanova (b)(4) received the information that total six heater cooler systems 3t, were used during that period.All the unit were replaced with devices that have undergone the retrofit upgrading procedure.Since it is unknown the serial number of the heater cooler system unit that was used during surgery no further investigation could be performed.With the information provided the relation between the involved device and patient contamination could not be confirmed.A review of the dhr for all six the devices that were used at that time did not identify any deviations or non-conformities relevant to the reported issue.Corrective actions are in progress for the reported issue.Livanova received the information that no further information will be provided by the customer therefore no further investigation can be performed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

In follow-up to a related news article livanova (b)(4) received a report that a patient who underwent a surgery on (b)(6) 2015 was found to be infected with mycobacterium chimaera.Confirmation of chimaera contamination was done on (b)(6) 2017.The patient has died.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, 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 Key: 7577385
• MDR Text Key: 110332314
• Report Number: 9611109-2018-01025
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/07/2018
• 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 Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR