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

Model Number MCH-1000(I)

Device Problem Contamination (1120)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 10/26/2020

Event Type  Injury  

Event Description

(b)(6) recently received information reasonably suggesting that the patient was exposed to m.Abscessus as a result of the use of a cardioquip modular heater-cooler during a surgical procedure on (b)(6) 2020.Further information is included on the attached page 3 of 3.Following the (b)(6) 2020 transplant procedure, the patient was discharged home on (b)(6) 2020 with sternal incision well healed.On (b)(6) 2021, the patient first reported redness, irritation, and bleeding from the previously healed sternal incision site, and an observed wound was concerning for infection.The m.Abscessus infection was confirmed on (b)(6) 2021 from intra-operative debrided tissue from the sternal incision.Due to the length of time between the patient's discharge and the prevalence of the organism in the community, a possible link between the mch unit used in the (b)(6) 2020 surgery and the patient's infection was not initially suspected, but a further investigation was conducted by the user facility out of an abundance of caution.(b)(6) hospital ("(b)(6)") learned that a culture obtained on (b)(6) 2021 from the sternal incision of a cardiac transplant patient resulted for m abscessus.The patient had received a heart transplant at (b)(6) on (b)(6) 2020 facilitated by a cardioquip mch device designated "unit f" 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 facility's 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: in addition to the use of 0.2 m filter to provide demineralized filtered water as recommended by the ifus, (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) 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)'s review established that its cleaning, disinfection, and maintenance of mch unit f met and/or exceeded the cardioquip ifus at all relevant times.(b)(6) sampled mch unit f and cultures from two locations grew m abscessus.Because the organism is ubiquitous in the environment, (b)(6) sent samples from unit f and patient cultures to (b)(6) for genomic analysis.On july 22, 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 128 surgical patients exposed to unit f between (b)(6) 2020 and the date the unit was removed from service.An epidemiological investigation confirmed mch unit f 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 transplant surgery.Pgfe analysis confirmed a genetic match 07/22/2021 between pt cultures and samples from the device.

• Brand Name: CARDIOQUIP HEATER-COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP ; college station TX
• MDR Report Key: 12554367
• MDR Text Key: 274446809
• Report Number: MW5104295
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 84