MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER (MCH); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(I)

Device Problems Material Discolored (1170); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

In (b)(6) the cardioquip heater-cooler devices were serviced by the manufacturer as part of routine maintenance.Biomedical engineering was contacted in (b)(6), next week by the manufacturer regarding "brown discoloration" noted in the internal water tubing in all three heater-coolers.Mycobacterium chimaera and mycobacterium abscessus infections associated with a high mortality rate in cardiac surgery patients heightened concerns and elicited alerts by the us food and drug administration several years ago.The mycobacteria are the most disinfectant-resistant bacteria which rapidly form a biofilm of high density.The source of m.Abscessus in heater coolers is the hospital water supply.The heater-coolers at (b)(6) hospital are filled with sterile water immediately after routing cleaning.However, the hospital water source is used to make ice which is then placed in the heater-coolers to be used during cpb.The (b)(6) hospital perfusion service is compliant and adherent to the manufacturer cleaning recommendations and maintains a scheduled rotation for equipment use and cleaning as depicted in the service line heater-cooler cleaning log book maintained within the pump room.Manufacturer response for cardiac perfusion heater-cooler, cardioquip heater-cooler (per site reporter).Manufacturer recommendations include shipping the units out to the company for culturing to determine the microbial load and replacing the internal water tubing if the microbial load exceeds the acceptable limits at a cost of approximately (b)(4) /unit.The units will be returned at no cost if the bacterial load is within acceptable range.This process is estimated to take 6-8 weeks per unit.Loaner devices are not available.

• Brand Name: CARDIOQUIP MODULAR COOLER-HEATER (MCH)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct; college station TX 77845
• MDR Report Key: 15064870
• MDR Text Key: 296227280
• Report Number: 15064870
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1