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

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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 a heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.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 a patient was found to be positive to mycobacterium chimaera.The patient had undergone a cardiac surgery for heart transplant in 2011.The patient was subjected to treatment with successful antibiotics therapy and now results negative to the tests.

Manufacturer Narrative

H.10: the serial number of the device used during procedure is unknown as well as the cleaning practise in use at the hospital at the time of the surgery.A complaints database analysis reveals that no complaints for device contamination were received from this hospital until the first submitted case on (b)(6) 2018.Through follow-up communication under a device contamination case from the same hospital livanova learned that the device was not cleaned regularly per the instruction for use.Indeed, the hospital uses a solution with the same recipe of clorex regular beach as cleaning solution.Moreover, the water quality monitoring is not performed and the hospital is user of reusable blankets which likely are a source of contamination.Based on the device maintenance lack encountered for 2019, it is reasonable to assume an improper maintenance also for 2011.The devices currently in use at the hospital are the followings: 16s16602,16s10548, 16s10547, 16s10549, 16s30060, 16s18584, 16s10550, 16s18614, 16s30205, 16s30698, 16s30700,16s12866.Seven devices manufactured after the surgery in 2011 can be excluded from the ones being in use since then.The possibly involved device are the followings: 16s10548, 16s10547, 16s10549, 16s10550 (all manufactured in june 2015) and 16s12866 (manufactured in november, 2011).A service history check has been performed for this devices and did not identify any deviations relevant to the reported event in 2011.The root cause remains unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9755140
• MDR Text Key: 197109070
• Report Number: 9611109-2020-00140
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1