MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(I)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 12/28/2022

Event Type  Injury  

Event Description

The patient underwent a heart transplant procedure for ischemic cardiomyopathy on (b)(6) 2021, requiring use of cardioquip heater cooler unit during the surgery.He has a past history of cabg in 2014, done at a different facility, but no obvious signs of infection at time of heart transplant surgery.He developed a non-healing sternal wound that let to evaluation back in the operating room on (b)(6) 2022.At that time, previous sternal wires were removed, and noted cavity around sternal wires were sent for culture, including mycobacterial cultures.The patient's 2 mycobacterial cultures obtained at time of debridement have since grown the organism mycobacterium chimaera as identified by the microbiology lab.Because of the association of this particular organism, as well as use of heater cooler device, and sternal infection, we are submitting this possible adverse event, as suggested by fda alert in 2021.

• Brand Name: CARDIOQUIP HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP
• MDR Report Key: 16294822
• MDR Text Key: 308884947
• Report Number: MW5114654
• 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: Physician
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCH-1000(I)
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White