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

Model Number MCH-1000(I)

Device Problem Biofilm coating in Device (1062)

Patient Problems Bacterial Infection (1735); Death (1802); Sepsis (2067); Multiple Organ Failure (3261)

Event Date 01/08/2021

Event Type  malfunction  

Event Description

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 used during the surgery was 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, but they were unable to suggest a way to remediate the problem and do not have loaner machines available.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.

Event Description

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 the machine.The manufacturer but they were was unable to suggest a way to remediate the problem and do not have loaner machines available.The unit has been removed from service.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.It 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.

Event Description

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 said they would not 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.It 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.

• Brand Name: CARDIOQUIP MODULAR COOLER-HEATER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct; college station TX 77845
• MDR Report Key: 11357684
• MDR Text Key: 232805384
• Report Number: 11357684
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2190 DA