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

Model Number 16-02-82

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 08/10/2017

Event Type  Injury  

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 with the customer livanova (b)(4) learned that the devices have been cultured regularly and have tested positive for contamination in the past.However, it was also reported that they have been able to get them clean.It is unknown if the device(s) was contaminated at the time of surgery, or if the reported surgery is linked to the device in any way.The customer reported that no further information will be provided regarding this incident until the internal investigation is completed.Through follow-up communication with the customer, livanova (b)(4) learned that the device has been tested.However, the results of the testing have not yet been provided.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 (mw5071894) which states that a patient became infected with mycobacterium abscessus and developed a sternal wound infection.The report indicated that the sternal wound infections identified at the facility are suspected to be related to the use of the heater-cooler device.However, at the time the user report was filed, a correlation had not yet been confirmed by the facility.On (b)(6) 2017, an article was identified in the advocate ((b)(6)) which identified 12 patients reportedly infected with mycobacterium abscessus.The article states that the patient was hospitalized due to the infection.The facility was allegedly able to trace the source to a single operating room and a single device which the facility believes caused the issue.However, the article did not explicitly state that mycobacterium abscessus has been identified in the device.The article reported that the suspected device has been replaced and ongoing environmental surveillance of the operating rooms has not shown any contamination with the organism beyond the involved device.

Manufacturer Narrative

Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.During follow-up communication on november 29, 2017, the customer provided an additional user medwatch report, which reported 11 patients.The report alleged that samples were taken from the involved device on (b)(6) 2017, and the samples tested positive for mycobacterium abscessus.

Manufacturer Narrative

Patient identifier: (b)(6).The user report stated that the date of therapy was (b)(6) 2017, and that the original surgery was an asd closure.The patient is reportedly allergic to penicillin and vancomycin.The medwatch report stated that wound cultures obtained on(b)(6) 2017 tested positive for mycobacterium abscessus.On december 28, 2017, livanova (b)(6) received an updated medwatch report from fda relating to this case (mw5071894).

• 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: 6939085
• MDR Text Key: 89020147
• Report Number: 9611109-2017-00792
• 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: Risk Manager
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-82
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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): Life Threatening; Other
• Patient Age: 8 YR
• Patient Weight: 24