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 Problems Bacterial Infection (1735); Death (1802)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.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 heater-cooler system 3t.The incident occurred in (b)(6).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 review revealed no device contamination complaints received from this hospital.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Through literature review livanova became aware of a (b)(6) years old male patient with a disseminated m.Chimaera infection following aortic dissection surgery in 2015.The patient developed an aortic root aneurysm diagnosed by echocardiogram in 2016, requiring redo-sternotomy and a bentall procedure in 2017.Medical history included cachexia and dorsalgia with a work/up revealing vertebral osteomyelitis with an epidural abscess, bone marrow and pulmonary infiltration with fluid collection around the aortic graft.The patient was subjected to antibiotics for one month before the explanation of infected foreign material, mediastinal debridement and aortic reconstruction.Complications included septic shock, respiratory and renal failure, mediastinitis and four distal aortic anastomotic dehiscences from friable tissue and persistent infection.He required wide debridement of infected mediastinal tissues and underwent a delayed vertical rectus abdominis myocutaneous flap closure of the chest.Days later the patient had recurrent active bleeding from his sternum and developed hemorrhagic shock ending with patient death.Within the article it is stated that the hospital used heater/cooler 3t systems.

Manufacturer Narrative

H.10: please find the article attached in the dedicated section.

Event Description

See initial.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10688573
• MDR Text Key: 211623994
• Report Number: 9611109-2020-00575
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death