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

Model Number 16-02-85

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Weight Changes (2607)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided.Patient weight was not provided.The serial number 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) implemented a field safety notice for disinfection and cleaning of sorin heater-cooler devices.The z number is z-2076/2081-2015.(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).The user medwatch report provided by the customer included multiple serial numbers.However, follow-up communication with the customer regarding a separate incident revealed that the facility does not track which unit is used for a given case, so it is unknown which of the units at the facility was used for the procedure.During this communication, livanova (b)(4) also learned that the units at the facility have tested positive for mycobacterium chimaera (reference medwatch report numbers 9611109-2016-00062, 9611109-2016-00217, 9611109-2016-00283, 9611109-2016-00608 and 9611109-2017-00323).The customer reported that the units were originally placed inside the operating room during use.However, the facility updated the procedure and the units are now placed outside the operating room during use.It is unknown when this procedural change was made.The customer also reported that the facility has always followed the disinfection procedure according to the instructions for use (ifu).A review of the dhrs for all potentially involved devices did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) has initiated corrective action to investigate this type of 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 july 20, 2017, livanova (b)(4) received a user medwatch report ((b)(4)) which states that a patient who underwent aortic valve replacement in 2015 was seen at another facility for a five month history of fatigue, weight loss and pancytopenia.An afb blood culture was taken and tested positive for non-tuberculous mycobacterium.The facility alleged that the infection is related to the use of a heater-cooler system 3t based on when the procedure was performed.The patient was hospitalized for the infection and a follow-up visit is planned.

• Brand Name: HEATER-COOLER SYSTEN 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: 6805254
• MDR Text Key: 83061970
• Report Number: 9611109-2017-00647
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• 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
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 67 YR