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 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

During preventative maintenance, photos of tubing were sent to cardioquip epidemiology by a service technician onsite.Due to the discoloration of the tubing, epidemiology recommended that the device undergo an internal water path replacement.Cardioquip notified the customer of the potential bacterial contamination/recommendation and provided a quote for the repair via email on (b)(6) 2022.There has been no response to the recommendation as of the date of this report.

Event Description

Due to brown discoloration around the hose clamps, cardioquip epidemiologist recommends an internal water pathway replacement.

Manufacturer Narrative

The customer accepted cardioquip's recommendation for the device to receive an internal water pathway replacement.When cardioquip received the device, an hpc test was performed to gain a quantitative analysis of the water quality.The results came back outside of cardioquip's specifications for bacterial contamination.An internal water pathway replacement was performed on the device to return it to specification.Following the repair, the device passed inspection and is fully functional.

Event Description

Due to brown discoloration around the hose clamps, cardioquip epidemiologist recommends an internal water pathway replacement.

• 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: 16454653
• MDR Text Key: 310371839
• Report Number: 3007899424-2023-00029
• 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: 08/07/2023

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: 02/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• 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