MAUDE Adverse Event Report: CARDIOQUIP CARDIQUIP MCH-000(I) HEATER COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(I)

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Microbial contamination of heater cooler device water reservoirs potentially contributing to cardiac surgical site infections.Eleven patients developed pseudomonas aeruginosa sternal surgical site infection (ssi) a median of 24 days (range, 11-54 days) after undergoing median sternotomy incision with use of cardiopulmonary bypass with the cardioquip heater cooler device for valve replacement (n=7) or cabg (n=4) cardiac surgical procedures.Five different cardioquip mch-1000(i) devices were utilized for these 11 cardiac surgeries.The water reservoir of one of the heater cooler devices used for 4 of the 11 procedures and one additional heater cooler device not used for any of the 11 procedures both grew p.Aeruginosa.The heater cooler devices had been maintained and cleaned according to the manufacturer's instructions for use.Both the ice machines and the potable water used to fill and clean the water reservoirs used 0.2 micron microbiologic filters.Nine available patient and 3 environmental p.Aeruginosa isolates were sent out for whole genome sequencing (wgs) analysis to assess strain relatedness.Wgs analysis demonstrated that 8 of 9 patient isolates were the same strain type, whereas none of 3 environmental isolates were related to any of the patient isolates or each other.Therefore, the microbial contamination of the heater cooler devices is not directly linked to the outbreak of cardiac ssi.Following modification of the procedures for intraoperative use and cleaning of the cardioquip devices, no additional cases of p.Aeruginosa ssi have been identified among patients undergoing cardiac surgery procedures.Therapy dates: (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: CARDIQUIP MCH-000(I) HEATER COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP; college station TX 77845
• MDR Report Key: 12160451
• MDR Text Key: 261520744
• Report Number: MW5102484
• Device Sequence Number: 3
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MCH-1000(I)
• Is the Reporter a Health Professional?: Yes
• 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): Disability