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

Model Number MCH-1000(I)

Device Problem Microbial Contamination of Device (2303)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

Cardioquip epidemiology observed potential contamination of a device.Due to the discoloration of the tubing, epidemiology recommended that the device receive hpc testing to provide a quantitative assessment of the water quality.The customer was notified of the potential contamination and recommendation via email.Following this, the customer requested an internal water path replacement on 9/22/23.Currently cardioquip is waiting to perform this service.A follow-up will be filed if any additional information or information that corrects this report is obtained.

Event Description

Upon inspection of the internal components/tank, cq epidemiology has identified potential contamination with the unit.Based on our findings, cardioquip recommends performing heterotrophic plate count (hpc) testing on the impacted unit to provide a quantitative assessment of water quality.

Manufacturer Narrative

Following test results outside of cardioquip specifications for water quality, cardioquip recommended that the device receive an internal water pathway replacement.The customer sent the device to cardioquip for repair.The device was returned to specification via an internal water pathway replacement.Following the repair, the device passed inspection and is fully functional.

Event Description

Upon inspection of the internal components/tank, cq epidemiology has identified potential contamination with the unit.Based on our findings, cardioquip recommends performing heterotrophic plate count (hpc) testing on the impacted unit to provide a quantitative assessment of water quality.

• Brand Name: CARDIOQUIP MODULAR COOLER HEATER
• Type of Device: 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: 18375708
• MDR Text Key: 331368677
• Report Number: 3007899424-2023-00490
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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 Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1