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

Model Number MCH-1000(I)

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

Patient Problems Bacterial Infection (1735); Multiple Organ Failure (3261)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Cardioquip personnel were sent to the user facility, ucsf (b)(4).Cardioquip personnel met with the ucsf personnel in the biomed shop where the suspect device was located.Cardioquip went over the cleaning & disinfection procedure.Ucsf suggested they put 6 gallons of 3% h2o2 in the device and run it and we stated that we could not recommend any other cleaning & disinfection procedure outside of our ifu.The clinical engineer discussed that he had performed particulate testing using their particle tester and the results were zero.The clinical engineer then communicated that he believes at some point the cardioquip devices at ucsf mission bay were not being maintained, according to the cardioquip ifu, for an extended period of time and that "seeded the device with bacteria." the clinical engineer also mentioned that they were not having the same issue at their ucsf - parnassus campus, where they are using distilled water, compared to using.22 m filtered water at ucsf - (b)(4).Ucsf personnel requested that no tubing or disassembly take place while cardioquip was onsite and stated that the clinical engineer would disassemble the device to investigate where additional biofilm growth may be within the device using an endoscope.Cardioquip was not given access to physically inspect the suspect device, the side panel was opened and personnel could visually see the internal tubing but were not given the opportunity to visually inspect the suspect device in further detail.Cardioquip requested to take water samples from the device and the facility water sources, ucsf infection control denied cardioquip's request to take samples.Further, ucsf infection control stated that samples were obtained from the suspect device and they were still awaiting the results.Cardioquip asked for a copy of the laboratory results upon receipt by ucsf.Per ucsf's mdr (b)(4), ucsf did receive results and stated that the water sample taken from the cardioquip heater-cooler did not contain the same bacteria that was found to be the cause of the patients' infection.Cardioquip has not received these results.

Event Description

Describe the event or problem: adolescent female patient developed serratia bacteremia/sepsis after cardiac and renal transplantation, leading to multiorgan failure and transition to comfort care and later expired.As part of the follow-up investigation, the heater-cooler and refrigeration module used during the surgery were examined.During the inspection, it was noted that the tubing inside the machine had extensive buildup of biofilm.While it is unknown whether this contributed to the infection, it was very concerning.These machines are on a quarterly cleaning/disinfection schedule.While it is possible the machine wasn't cleaned on schedule or according to the instructions for use (ifu) at some point in the past, records indicate it has been on schedule for at least the past year.It appears that once the biofilm gets established, the cleaning/disinfection process in the ifu is not adequate to remove it.There was at least one preventive maintenance during the last year performed by the vendor but there is no mention of biofilm in the pm report.We contacted the manufacturer about the biofilm, and the manufacturer came on site to inspect machine.They were unable to suggest a remediation other than to replace all the contaminated components or buy a new machine.Replacing all the components is extremely labor intensive and they do not have loaner machines available.They also s.Aid they would net sell us the required parts.The ifu does not state what an acceptable level of biofilm is or how to mitigate extensive buildup.The preventive maintenance instructions in the manual do not include checking for biofilm buildup on the interior pump tubing.I is unknown if the tubing has ever been changed since the device was received.We performed aerosol emission testing and found nothing conclusive.A lab test of the water from the heater cooler unit (hcu) came back negative for serratia bacteremia.The facility has 7 of the larger systems and 17 of the smaller systems.The associated user facility report is mdr (b)(4).

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.Customer was noticing poor patient outcomes, however, did not specify how many patients or what their outcomes were.Serratia bacteremia was found in a patient.The device was exhibiting 'biofilm', however lab results from the customer came back negative for serratia bacteremia and the cfu count was within acceptable limits.Cardioquip was not given access to physically inspect the device.

Event Description

Customer reported the internal tubing was very dirty, this was found while inspecting devices after there were an unknown number of poor patient outcomes.Serratia bcteremia was found in the patients, however was not present in the device.Cardioquip was not given access to physically inspect the suspect device, the side panel was opened and we could visually see the internal tubing but were not given the opportunity to visually inspect the suspect device "up-close.".

• 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: 11604834
• MDR Text Key: 244864190
• Report Number: 3007899424-2021-00002
• 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,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2017
• 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
• Patient Age: 6 YR
• Patient Sex: Female