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

Model Number MCH-1000(M)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

Based on the guidance received from the fda letter to healthcare provider, "potential risk of infection during cardiac surgery when using the cardioquip modular cooler-heater device" dated september 30th, 2020 and device concerns raised in the letter, we are submitting a voluntary report.On 3/20/24 (b)(6) medical center identified bioburden on the cardioquip machine.The machines were removed immediately from use and sequestered while the machines were evaluated for contamination by the manufacturer by heterotrophic plate count (micro culture).Lab cultures resulted in 507,000 mpn/ml which is well above the accepted value of <100 mpn/ml.The machine underwent full annual preventive maintenance and sanitation with manufacturer's approved disinfectant and re-cultured.The re-culture returned within normal limits and the machine was approved to be returned back to service.No patients were exposed and no gaps have been identified with maintenance at this point in time but a gap analysis is underway.The serial number for the unit is (b)(6).

• Brand Name: HEATER COOLER DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP
• MDR Report Key: 19208698
• MDR Text Key: 341505025
• Report Number: MW5154406
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Patient Age: 149 YR
• Patient Sex: Prefer Not To Disclose