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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).
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Manufacturer (Section D)
8422 calibration ct.
college station TX 77845
Manufacturer (Section G)
8422 calibration ct.
college station TX 77845
Manufacturer Contact
charley ford
8422 calibration ct.
college station, TX 77845
MDR Report Key11604834
MDR Text Key244864190
Report Number3007899424-2021-00002
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMCH-1000(I)
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown