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 04/08/2024

Event Type  malfunction  

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 reperform cleaning and disinfection procedures detailed in the ifu and reperform hpc testing, (2) have the device receive an internal water pathway replacement or, (3) participate in cardioquip's trade in program.These options would return the device to specification and full functionality.These options were relayed to the customer via email.As of the date of this report the customer has not responded to these options.

Event Description

Upon inspection of the internal components/tank, our technician identified potential contamination with the unit.The technician took pictures of the internal tubing of the device and forwarded them to cq for review.Based on our findings, cardioquip recommends performing heterotrophic plate count (hpc) testing on the impacted unit to provide a quantitative assessment of water quality.Hpc testing concluded that the device had a bacterial count outside of cardioquip specifications on 04/08/2024.

• 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
• MDR Report Key: 19217682
• MDR Text Key: 341516769
• Report Number: 3007899424-2024-00060
• 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: Inspection
• Type of Report: Initial
• Report Date: 04/11/2024

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: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2018
• 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