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

Model Number MCH-1000(I)

Device Problems Contamination (1120); Appropriate Term/Code Not Available (3191)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device has yet to be received from the customer.Based on review of the complaint and photo provided by the customer, of the internal tubing of their devices, there appears to be a growth within the tubing that is consistent with bacterial biofilm growth.The overall appearance, for the internal tubing, has a high probability of being contamination with bacteria over the design specification.This is based on testing performed on devices similar in appearance.Once the investigation has been completed, cardioquip will complete an additional report.

Event Description

While performing a cleaning procedure, the customer took pictures of the internal tubing of the device and sent them to cq service for review.After cq staff reviewed the photos, due to the yellow discoloration of the tubing, an internal water path replacement was recommended.

Event Description

While performing a cleaning procedure, the customer took pictures of the internal tubing of the device and sent them to cq service for review.After cq staff reviewed the photos, due to the yellow discoloration of the tubing, an internal water path replacement was recommended.

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.The device has not been received by cardioquip for investigation, though upon review of additional photos provided by the customer, the internal tubing did not meet the manufacturers definition of bacteria contamination, due to the appearance of the internal tubing being within visual specification.

• 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: 12807148
• MDR Text Key: 282279264
• Report Number: 3007899424-2021-00044
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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 Operator: Health Professional
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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