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

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Unspecified Infection (1930)

Event Date 05/17/2017

Event Type  Injury  

Event Description

Facility received an alert in 2016 regarding the device and possible mycobacterium contamination.According to the perfusion dept, all the necessary interventions were performed.Pt utilized the device at the facility on (b)(6) 2017.He was readmitted (b)(6) 2019, blood sample confirmed intracellularly mycobacterium infection.Sample was sent to the (b)(6) lab for further testing.(b)(6) 2020 the test came back positive for chimaera.

• Brand Name: HEATER-COOLER SYSTEM SORIN
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): 3T / LIVANOVA DEUTSCHLAND GMBH
• MDR Report Key: 9727671
• MDR Text Key: 180118904
• Report Number: MW5093038
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR