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

Model Number MCH-1000(M)

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Photos of tubing were submitted by a cardioquip technician and sent to cardioquip epidemiology for investigation during an onsite service visit.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 on 11/02/23.As of the date of this report, there has been no response to the recommendation.A follow-up will be filed if any additional information or information that corrects this report is obtained.

Event Description

Cq technician notified cq service via airtable that the internal tubing of this device was suspect of contamination during an on-site inspection.The technician took pictures of the internal tubing which were sent to cardioquip for review.Cq director of operations and epidemiologist reviewed the pictures, and recommended that the device receive hpc testing to gain a quantitative analysis of water quality.This issue was identified on 11/01/2023.

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 the device receive an internal water pathway replacement.The customer then 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

Cq technician notified cq service via airtable that the internal tubing of this device was suspect of contamination during an on-site inspection.The technician took pictures of the internal tubing which were sent to cardioquip for review.Cq director of operations and epidemiologist reviewed the pictures, and recommended that the device receive hpc testing to gain a quantitative analysis of water quality.This issue was identified on (b)(6) 2023.

• 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: 18220361
• MDR Text Key: 329156873
• Report Number: 3007899424-2023-00459
• 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: 02/07/2024

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(M)
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• 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