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 Problems Bacterial Infection (1735); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2020

Event Type  Death  

Manufacturer Narrative

Cardioquip has not received the device.Once more information has been gathered, an additional report will be submitted.According to information (b)(6) ( (b)(6) hospital) sent to cardioquip via (b)(6), dated (b)(6) 2021, "the patient continued to have serious post-surgical complications and passed away several months later." based on the information that has been provided to cardioquip, at this time, it is not clear whether (b)(6) believes this death is attributable to the alleged contaminated cardioquip device or if the patient died of other complications.

Event Description

(b)(6) hospital ((b)(6)) learned that a blood culture obtained on (b)(6) 2020 from a lung transplant 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 g" 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: in addition to the use of 0.2 m filter to provide demineralized filtered water as recommended by the if us, (b)(6) also uses a prefilter ahead of the 0.2 m filter.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.(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.(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 g met and/or exceeded the cardioquip ifus at all relevant times.(b)(6) sampled mch unit g and a culture from one location sampled grew m immunogenum.As part of a larger investigation, (b)(6) also sampled two other mch units present in hospital operating rooms and suspected of being associated with exposure to m.Abscessus in two other patients.Because m.Abscessus is ubiquitous in the environment, (b)(6) sent samples from the mch units and the patient cultures to university of (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 this patient's sample, those of the other two patient samples, and the cultures from the other two mch units.A records review has revealed no other known m.Abscessus cases among 127 surgical patients exposed to unit g between (b)(6) 2020 and the date the unit was removed from service.An epidemiological investigation and environmental cultures confirmed mch unit gas 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 g) as a potential vector for bacterial transmission resulting in a patient infection.After reviewing the investigation, cardioquip identified that the user facility had numerous post-surgical complications unrelated to any infection, as well as the bacteria cultured from the patient was not the same organism as what was identified in the cardioquip heater-cooler.At this time, cardioquip's investigation does not support the conclusion that the cardioquip heater-cooler was the vector of exposure for this patient's infection, due to the bacteria found in the heater-cooler and in the patient were of different species.The user facility mentioned that in the epidemiological investigation, it was determined that no other known m.Abscessus cases occurred among 127 surgical patients exposed to "unit g" between september 2020 and the date the units were removed from service.Following our most recent communication, (b)(6) indicated that "(b)(6) 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.

Event Description

The user facility recently received information reasonably suggesting that the patient may have been 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 blood culture obtained on (b)(6) 2020 from a lung transplant 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 g" 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)'s procedures adhered to and, in many aspects exceeded the processes set forth in the cardioquip ifus.(b)(6)'s 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 g met and/or exceeded the cardioquip ifus at all relevant times.(b)(6) sampled mch unit g and a culture from one location sampled grew m immunogenum.As part of a larger investigation, (b)(6) also sampled two other mch units present in hospital ors and suspected of being associated with exposure to m.Abscessus in two other patients.Because m.Abscessus is ubiquitous in the environment, (b)(6) sent samples from the mch units and the 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 this patient's sample, those of the other two patient samples, and the cultures from the other two mch units.A records review has revealed no other known m.Abscessus cases among (b)(4) surgical patients exposed to unit g between (b)(6) 2020 and the date the unit was removed from service.An epidemiological investigation and environmental cultures confirmed mch unit g 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.

• 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: 12763367
• MDR Text Key: 280449306
• Report Number: 3007899424-2021-00035
• 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: 04/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White