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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  malfunction  

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.The unit was producing a "smelly white fluid".No additional investigation is available as the customer has not provided any additional information regarding this issue after multiple attempts for follow-up.

Event Description

Customer reports that their device is producing a "smelly white fluid" while not in use.

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

The customer reported that eleven patients developed pseudomonas aeruginosa sternal surgical site infection.Five different devices were used for these eleven cardiac surgeries.The water reservoir of one of the devices used for four of the eleven procedure and one additional device not used for any of the eleven procedures both grew p.Aeruginosa.The microbial contamination of the devices is not directly linked to the outbreak of cardiac ssi.

• 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: 14744970
• MDR Text Key: 302579076
• Report Number: 3007899424-2022-00018
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1