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 10/26/2022

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 an assessment of the water quality be performed to test for potential bacterial contamination.Cardioquip notified the customer of the potential contamination and recommendation and provided pricing for water sample test kits via email on 2/21/23.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 epidemiology recommends an internal water pathway replacement.

Manufacturer Narrative

The user facility tested the suspect device for contamination following cardioquip's recommendation.Because the hpc results came back outside of cardioquip specifications, cardioquip epidemiology recommended that the device receive an internal water pathway replacement.Following cardioquip receiving the suspect device and performing an investigation, the device was returned to specification via an internal water pathway replacement.After being repaired, the device passed inspection and is fully functional.

Event Description

Due to brown discoloration around the hose clamps, cardioquip epidemiology 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: 16456373
• MDR Text Key: 310592902
• Report Number: 3007899424-2023-00026
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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