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

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Mw5102484 received in the mail on july 27, 2021 stating the following: 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).Follow-up with the customer identified a total of 11 patients were involved with this medwatch report.A separate report is being filed for each patient, however customer was unable to provide 2 serial numbers.Cardioquip's review, based on the information described in the user facility medwatch report (mw5102484), the information describes that the patient isolates and environmental isolates are not related thus indicating that the heater-cooler used during the patient's surgery is not directly linked to the patient's infection.This is supported by the whole genome sequencing (wgs) that (b)(6)(medical director of healthcare epidemiology) reported was conducted in the user facility medwatch report.

Event Description

On (b)(6) 2021 mv repair.Developed sternal surgical site infection (osteomyelitis) with p.Aeruginosa with secondary bacteremia on (b)(6) 2021.Required sternal debridement, wire removal, pectoralis flaps and antibiotics.

Manufacturer Narrative

The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.Customer reported 11 instances of patient sternal infections.There were 5 devices used among the 11 surgeries.One device that was used in 4 of the surgeries was tested for microbial contamination along with a device not used in any of the surgeries.The sample contamination levels were noted as "few" and "many".The customer noted that the strains found were not related to those found in the patients; therefore, the microbial contamination of the device was not directly linked to the infection.Additionally, the customer reported that they identified environmental issues contributing to the contamination of the device despite following the ifu for periodic disinfection and the use of microbial water filter.

Event Description

Customer reports bacterial contamination.

• 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: 12381020
• MDR Text Key: 273606486
• Report Number: 3007899424-2021-00024
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: QUEST MPS-2 CARDIOPLEGIA UNIT
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White