MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE

Model Number	MCH-1000(I)
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A cardioquip technician submitted photos of tubing to epidemiology for investigation during an on-site inspection.Due to the discoloration of the tubing, epidemiology recommended that the device receive hpc testing to provide a quantitative assessment of water quality.Following test results outside of cardioquip specifications, cardioquip recommended that either (1) the customer perform cleaning and disinfection procedures detailed in the ifu and reperform hpc testing, (2) the device receive an internal water pathway replacement, or (3) the customer participate in cardioquip's trade-in program.The customer chose to reperform cleaning and disinfection and hpc testing.
Event or Problem Description
A cardioquip (cq) customer notified cq service that the internal tubing of this device was suspected of contamination.The cq director of operations and epidemiology recommended that the customer perform a quarterly cleaning and disinfection procedure according to the device instructions for use (ifu).Hpc testing is also recommended to provide a quantitative assessment of water quality.No patient involvement was reported.Hpc test results outside of cq specifications for water quality were received on (b)(6) 2026, indicating device contamination.

• Brand Name: CARDIOQUIP MODULAR COOLER HEATER
• Common Device Name: CARDIOPULMONARY BYPASS DEVICE
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct.; college station TX 77845
• Manufacturer (Section G): CARDIOQUIP, LLC; 8422 calibration ct.; college station TX 77845
• Manufacturer Contact: charley ford ; 8422 calibration ct.; college station, TX 77845 ; 9796910202
• MDR Report Key: 25316423
• Report Number: 3007899424-2026-00119
• Device Sequence Number: 9893757
• Product Code: DWC
• UDI-Device Identifier: 00860000846103
• UDI-Public: (01)00860000846103(11)170519
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K102147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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
• Operator of Device: Health Professional
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown