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U.S. Department of Health and Human Services

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

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
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.

 
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Brand NameCARDIOQUIP MODULAR COOLER-HEATER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP, LLC
8422 calibration ct
college station TX 77845
MDR Report Key11357684
MDR Text Key232805384
Report Number11357684
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received02/22/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMCH-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 FDA02/12/2021
Device Age4 yr
Event Location Hospital
Date Report TO Manufacturer02/22/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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