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

Model Number MCH-1000(I)

Device Problem Contamination (1120)

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

Event Date 09/06/2023

Event Type  malfunction  

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, epidemiology recommends performing heterotrophic plate count (hpc) testing on the impacted unit to provide a quantitative assessment of water quality.

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 09/12/23.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.

• 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: 17872071
• MDR Text Key: 324935828
• Report Number: 3007899424-2023-00387
• 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
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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