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

Model Number MCH-1000(M)

Device Problems Contamination (1120); Microbial Contamination of Device (2303); Excessive Heating (4030)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

Upon visual inspection of the device, while on-site at cardioquip, there was yellow colored growth within the tubing consistent with bacterial biofilm growth.The overall appearance, of the internal tubing, indicates a high probability of being contaminated with bacteria over the design specification.This is based on testing performed on devices similar in appearance.The problem with overtemping is found to be an issue within the software version that was on the device at the time of the complaint.The software was rolled back to a stable, functioning version.A design change addressing software issues is in the process of being implemented.

Event Description

Customer reports that their device is overheating while in use on a patient, at which point the device was swapped out and replaced with a backup device.The customer states that this issue did not impact the patient's health negatively.Upon visual inspection of the device, while on-site at cardioquip, there was yellow colored growth within the tubing consistent with bacterial biofilm growth.

Manufacturer Narrative

The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection while the device was being inspected at cardioquip, it was found to contain yellow-colored growth within the internal tubing that is typically consistent with bacterial contamination.The device was tested and found to contain bacterial contamination levels that exceeded acceptable limits.The device went through an internal water pathway replacement and was tested afterwards.According to lab results, the cfu count was within the acceptable limits.

Event Description

Upon visual inspection of the device, while on-site at cardioquip, there was yellow colored growth within the tubing consistent with bacterial biofilm growth.The overall appearance, of the internal tubing, had a high probability of being contaminated with bacteria passed the design specifications of >500 cfu/ml.This is based on testing performed on devices similar in appearance.

• 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: 12929641
• MDR Text Key: 284287160
• Report Number: 3007899424-2021-00046
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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?: No
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1