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

Model Number MCH-1000(I)

Device Problems Biofilm coating in Device (1062); Microbial Contamination of Device (2303)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

The customer ((b)(6)) reported that the tubing referenced in the complaint is not available for investigation.Tubing of a similar appearance from another user facility was sent to the texas a&m veterinary medical diagnostic laboratory for fungal and bacterial identification.Based on review of the complaint and photo provided by the customer, of the external tubing of their devices, there appears to be a dark spotted growth within the tubing that is consistent with bacterial growth.The overall appearance, from the external tubing, has a high probability of being contaminated with bacteria over the design over the design specifications.This is based on testing performed on devices with similar dark growth within the internal and/or external tubing.Upon receving additional information from the completion of the investigation or the user facility, cardioquip will file supplementary reports.

Event Description

Customer shared the attached picture with, (b)(6) ((b)(6) surgical) of their dam tubing."(b)(6) explained that they are in fact changing the tubing quarterly with every cleaning and this growth has happened within a couple weeks after cleaning the device.This has occured at least 3 times.

Event Description

Customer shared the attached picture with, brianne sylvia (shamrock surgical) of their dam tubing."sean explained that they are in fact changing the tubing quarterly with every cleaning and this growth has happened within a couple weeks after cleaning the device.This has occured at least 3 times.

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.Cardioquip performed a lab analysis of hoses that shared relevant characteristics to identify the nature of the contamination.The lab analysis identified rhinocladiella similis (fungus)as the contaminant causing the reported spotted hoses.

• 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: 12532796
• MDR Text Key: 273341660
• Report Number: 3007899424-2021-00031
• 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: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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