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 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

A customer requested device testing due to alleged bacterial contamination.Hpc testing was performed 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 agreed to that service.Currently cardioquip is waiting to receive the device in order to perform the service.Following the internal water pathway replacement, the device will be returned to specification.A follow-up will be filed if any additional information or information that corrects this report is obtained.

Event Description

Based on these results (10161342 -137000 mpn/ml), this device is above the acceptable limits for water quality in cardioquip cooler-heater.To remediate the device contamination, the facility can either perform an internal water path replacement (iwpr) or participate in cardioquip's trade-in program.

Event Description

Based on these results (10161342 -137000 mpn/ml), this device is above the acceptable limits for water quality in cardioquip cooler-heater.To remediate the device contamination, the facility can either perform an internal water path replacement (iwpr) or participate in cardioquip's trade-in program.

Manufacturer Narrative

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.

• 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: 18095604
• MDR Text Key: 327742990
• Report Number: 3007899424-2023-00420
• 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: 11/08/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1