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 Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.The date of the event will be provided in a supplemental report if made available.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 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).Through follow-up communication with the chief perfusionist under previous cases from the same hospital livanova learned that the water in the heater-cooler systems 3t in use is changed every day and they are stored dry.This is not in alignment with current instruction for use however reportedly the devices are very clean and there is no sign of biofilm.The devices are located inside the operating theatre during use.We are currently waiting to know the result of microbial sampling performed at customer site.Reportedly the tests are still in progress.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 report of one more patient tested positive for an unknown type of ntm bacterium at (b)(6) center.Reportedly he was a vad patient who undergone cardiac surgery in (b)(6) 2019.The serial number of the heater-cooler system 3t used during the surgery is unknown.

Manufacturer Narrative

H.10: the serial numbers of the devices used for these surgery are unknown.However, two (2) over five (5) devices which were in use at the hospital resulted to be contaminated.Only one serial number has been provided (16s17668) and a follow up report for the other cases associated to this specific device has been filed.The second serial number remains unknown as well as the type of contamination.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: through follow-up communication with patient husband livanova learned that the patient was m.Chimaera positive.In addition, livanova learned that surgery date was (b)(6)2019.Reportedly, the post-surgery went fine.At six months post-surgery patient began feeling fatigued and was put on low dose of antibiotics.At nine months post-surgery a lump was found at the level of the sternum.Decision was made to undergo surgery to remove or replace her wires.At surgery, patient had sufficient sternal growth and surgeon decided to just remove the sternal wires.According to the husband, the surgeon noted that there was no sign of infection.During the surgery the surgeon had performed a needle biopsy of tissue near the sternum.Approximately 30 days after the surgery the patient received a call from the hospital and then put on antibiotic regimen which has interacted negatively with some other medications she was already taking (afib meds, etc.), and these medications were adjusted or removed to prioritize the ntm treatment.According to the husband, patient has suffered two strokes as a result of the medication adjustments/complications.The patient is expected to be on antibiotics for a total of 18-24 months.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned the device serial number which has been added to the dedicated d.4 section as well as udi code and manufacturing date of device has been added accordingly to section h.4.Service history review did not identify any information relevant to the reported issue.The device was upgraded with vacuum and sealing kit on february 26, 2020 after the surgery date ((b)(6) 2019).

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10199500
• MDR Text Key: 202581436
• Report Number: 1718850-2020-01098
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: 010403381790052811170512
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 05/28/2020; 05/28/2020; 06/15/2022
• Supplement Dates FDA Received: 07/29/2020; 10/29/2020; 06/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1