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

Model Number 16-02-85

Device Problem Biofilm coating in Device (1062)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.As the issue was discovered by a sorin group usa technician, it is unknown when the device became contaminated.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.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).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 biofilm was identified on all components of the heater-cooler system 3t that had been exposed to fluid during operation.This issue was noted by a livanova technician during maintenance on the device, which had been returned to sorin group usa for an unrelated issue.There was no patient involvement.

Manufacturer Narrative

Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova deutschland.During follow-up communication with the customer, livanova deutschland learned that no positive test results have been received for this unit and the user has not noticed any type of film in the device (thought the tanks were not inspected) or tubing.The device is used inside the operating room oriented away from the patient.There are no patient infections and the facility performs the cleaning procedure according to the instructions for use (ifu).Further visual inspection of the device was unable to confirm biofilm.The deposit appears to be inorganic in nature and may be corrosion or other deposit that formed from the bleaching process.During follow-up communication with the technician who discovered the issue, it was found that the term "biofilm" was used in general to state that there was deposit in the device.Livanova is unable to confirm if the substance is biofilm or not.Based on these findings, livanova deutschland has reevaluated this case as not reportable.This medwatch report is void.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• 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: 6726529
• MDR Text Key: 80512155
• Report Number: 9611109-2017-00548
• 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: company representative
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2013
• 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