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

Device Problem Microbial Contamination of Device (2303)

Patient Problems Abscess (1690); Bacterial Infection (1735); Pain (1994); Numbness (2415)

Event Date 02/19/2020

Event Type  Injury  

Event Description

This event involves a patient with a history of mitral valve replacement in early 2017; hyperlipidemia, hypertension, peripheral artery disease, and coronary artery disease with known thoracolumbar osteomyelitis and epidural spinal abscesses on daptomycin.The patient was recently admitted to hospital with worsening pain in his bilateral lower extremities, numbness in his anterior and lateral thighs, and progressive difficulty with urination.The patient underwent magnetic resonance imaging, which was notable for a slight increase in t3-4 and l4-5 abscesses.Nearly a week later, the patient underwent multi-level laminectomy and fusion for abscess drainage.A wound culture was sent on that day and processed in a reference lab and came back positive for mycobacterium chimera.M.Chimera infections have been previously linked to the use of the sorin heater-cooler at other institutions and can occur years after the cardiac surgical procedure.A sorin heater-cooler was in use at the time of this patient's mitral valve replacement back in early 2017.The patient will require prolonged treatment for the m.Chimera infection.The patient was discharged to an acute inpatient rehabilitation setting.

• Brand Name: HEATER-COOLER SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 9915422
• MDR Text Key: 186112395
• Report Number: 9915422
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2020,03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26645 DA
• Patient Weight: 83