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

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

Livanova's stöckert 3t heater-cooler.Serial number (b)(4) cultured.Results came back positive for m.Chimera post disinfection performed per ifu.Stockert manufactured in 2013.Fda safety report id # (b)(4).

• Brand Name: LIVANOVA 3T HEATER/COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH
• MDR Report Key: 14831204
• MDR Text Key: 294941123
• Report Number: MW5110527
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1