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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland manufactures the 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 deutschland received a mw5095558 report about a patient with blood cultures drawn and sent for m.Chimaera at another unknown facility.The patient undergone a cardiac surgery on 2018 at (b)(6).The heater-cooler 3t of the hospital was then tested and found positive to acid fast bacilli this year.The swabbs are being for further differentiation and to rule out m.Chimaera.The serial number of the heater-cooler unit used for the 2018 surgery is unknown.

Manufacturer Narrative

Through follow-up communication livanova learned that the device is placed inside the operating theatre during use with the fan directed away from the patient at an estimated distance of two meters from the surgery field.Livanova attempted to request additional information and it was not made available thus the current cleaning practise in place at the hospital and the serial number of device used during surgery remain 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.

Manufacturer Narrative

H.10: livanova learned the model and serial numbers of involved device, as well as the device manufacturing date.Information has been updated accordingly in the dedicated d.4 and h.4 sections.In addition, livanova learned that the patient underwent additional successful procedures (left heart catheterization, aortic balloon valvuloplasty, and valvular leak closure) in (b)(6) 2019.(b)(6) 2019, the patient developed a variety of symptoms and was evaluated for various medical issues.He was then transferred to mayo clinic in (b)(6) 2020 for further evaluation and reportedly mycobacterium chimaera was diagnosed at that time via blood cultures.The patient is on dialysis and antibiotics.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: livanova became aware that the patient passed away on (b)(6), 2021.B.1, b.2 sections have been updated according to additional information received.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10465488
• MDR Text Key: 204880470
• Report Number: 1718850-2020-01124
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Device Lot Number: 16S11703
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2021
• Device Age: 12 YR
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other