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

Model Number MCH-1000(I)

Device Problems Contamination (1120); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Cardioquip has not receviced the device.Once more information has been gathered, an additional report will be submitted.

Event Description

(b)(6) hospital learned that a culture obtained on (b)(6) 2021 from the driveline drainage of a cardiac surgical patient resulted positive for m abscessus.The patient had undergone a cardiac procedure at (b)(6) hospital on (b)(6) 2020 facilitated by a cardioquip mch device designated "unit d" by (b)(6) hospital.Cultures from the patient and the mch unit were collected for additional analysis.In the interim, (b)(6) hospital reviewed in detail records related to training of licensed perfusionists and the cleaning/disinfection procedures for the mch units.That review revealed that (b)(6) hospital's procedures adhered to and, in many aspects exceeded the processes set forth in the cardioquip ifus.(b)(6) hospital's extra procedures include, but are not limited to the following: in addition to the use of 0.2 m filter to provide demineralized filtered water as recommended by the if us, (b)(6) hospital also uses a prefilter ahead of the 0.2 m filter.On a routine monthly basis, (b)(6) hospital drains all water from the units and disinfects the water tanks monthly, as opposed to the quarterly basis suggested by the manufacturer.During this process, in addition to the cleaning and disinfection steps outlined in the manufacturer's ifus, (b)(6) hospital also lifts the condenser unit out for additional cleaning.(b)(6) hospital provides training for licensed perfusionists to conduct the periodic cleaning and disinfection procedures of the mch units.Initial and annual competencies are documented and reviewed by a supervisor.(b)(6) hospital conducts multi-disciplinary reviews to keep up-to-date on literature and/or adverse event reports related to heater-cooler machines and to review its own processes and documentation.(b)(6) hospital's review established that its cleaning, disinfection, and maintenance of mch unit d met and/or exceeded the cardioquip ifus at all relevant times.(b)(6) hospital sampled mch unit f and a culture from one location sampled grew m.Abscessus.Because the organism is ubiquitous in the environment, (b)(6) hospital sent samples from unit d and patient cultures to university of texas medical center-tyler for genomic analysis.On july 22, 2021, (b)(6) hospital received results from the laboratory demonstrating a genetic match between the samples.A records review has revealed no other known m.Abscessus cases among 80 surgical patients exposed to unit d between september 2020 and the date the unit was removed from service.An epidemiological investigation and environmental cultures confirmed mch unit d as the most likely source of the patient's exposure.Genetically similar m.Abscessus colonies were not isolated from environmental cultures taken from the room where the patient underwent the surgery.

Event Description

The user facility received information reasonably suggesting that the patient was exposed to m.Abscessus as a result of the use of a cardioquip heater-cooler during a surgical procedure on (b)(6), 2020.(b)(6) hospital (b)(6)") learned that a culture obtained on (b)(6) 2021 from the driveline drainage of a cardiac surgical patient resulted positive for m abscessus.The patient had undergone a cardiac procedure at (b)(6) on (b)(6) 2020 facilitated by a cardioquip mch device designated "unit d" by (b)(6).Cultures from the patient and the mch unit were collected for additional analysis.In the interim, (b)(6) reviewed in detail records related to training of licensed perfusionists and the cleaning/disinfection procedures for the mch units.That review revealed that (b)(6) procedures adhered to and, in many aspects exceeded the processes set forth in the cardioquip ifus.(b)(6) extra procedures include, but are not limited to the following: 1.In addition to the use of 0.2 micron filter to provide demineralized filtered water as recommended by the if us, (b)(6) also uses a prefilter ahead of the 0.2 micron filter.2.On a routine monthly basis, (b)(6) drains all water from the units and disinfects the water tanks monthly, as opposed to the quarterly basis suggested by the manufacturer.During this process, in addition to the cleaning and disinfection steps outlined in the manufacturer's ifus, (b)(6) also lifts the condenser unit out for additional cleaning.3.(b)(6) provides training for licensed perfusionists to conduct the periodic cleaning and disinfection procedures of the mch units.Initial and annual competencies are documented and reviewed by a supervisor.4.(b)(6) conducts multi-disciplinary reviews to keep up-to-date on literature and/or adverse event reports related to heater-cooler machines and to review its own processes and documentation.(b)(6) review established that its cleaning, disinfection, and maintenance of mch unit d met and/or exceeded the cardioquip ifus at all relevant times.(b)(6) sampled mch unit f and a culture from one location sampled grew m.Abscessus.Because the organism is ubiquitous in the environment, (b)(6) sent samples from unit d and patient cultures to (b)(6) medical center-(b)(6) for genomic analysis.On (b)(6), 2021, (b)(6) received results from the laboratory demonstrating a genetic match between the samples.A records review has revealed no other known m.Abscessus cases among (b)(4) surgical patients exposed to unit d between (b)(6) 2020 and the date the unit was removed from service.An epidemiological investigation and environmental cultures confirmed mch unit d as the most likely source of the patient's exposure.Genetically similar m.Abscessus colonies were not isolated from environmental cultures taken from the room where the patient underwent the surgery.

Manufacturer Narrative

The initial report provided by (b)(6) of which this investigation is based identified a cardioquip heater-cooler device (unit d) as a potential vector for bacterial transmission resulting in a patient infection.Cardioquip also identified another (b)(6) medwatch report detailing a second patient infection and unrelated cardioquip heater-cooler (unit f) that contained similar bacteria to the m.Abscessus identified in unit f.The method of genetic analysis used was pulse-field gel electrophoresis (pfge).Both surgeries occurred on the same day, (b)(6), 2020, and were performed with different cardioquip heater-coolers.At this time, cardioquip's investigation does not support the conclusion that the cardioquip heater-cooler was the likely vector of exposure for these two patient infections.The user facility mentioned that in the epidemiological investigation, it was determined that no other known m.Abscessus cases occurred among 80 surgical patients exposed to "unit d" and 128 surgical patients exposed to "unit f" between (b)(6) 2020 and the date the units were removed from service.Given the expansive use of the two cardioquip heater-coolers in question and the similarities between the two adverse events (i.E., the same date of surgery, and the similarity in bacteria found in the two heater-coolers and patients), it would be statistically imprudent to implicate the heater-cooler without first eliminating the possibility of a unified root cause.Other bacterial sources, such as a contaminated water source, may be more likely to result in two unrelated contamination events on the same day when compared to the likelihood of two independent transmission events.Furthermore, a definitive genomic analysis of the bacteria has yet to be performed.Preliminary (b)(6) investigations concluded that the bacteria found in the heater-cooler and patient were similar using pfge.Cardioquip has yet to perform a more robust analysis of the genome of the bacteria in question using more comprehensive analytical techniques, such as whole genomic sequencing (wgs).Following our most recent communication, (b)(6) indicated that "duke has not received any patient claims associated with these units." cardioquip is currently working with (b)(6) to identify a path forward for a more rigorous investigation of the cardioquip heater-cooler in question.Following termination of the investigation, additional information will be provided with this report.

• 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: 12763470
• MDR Text Key: 280538756
• Report Number: 3007899424-2021-00036
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2018
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White