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

Model Number MCH-1000(M)

Device Problem Microbial Contamination of Device (2303)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

In follow-up communication with the (b)(6) personnel, the (b)(6) personnel indicated they are utilizing genetic mapping to try and determine whether the pseudomonas aeruginosa found within the cardioquip device is the same, genetically, as what was found in the patients.(b)(6) also reported that multiple sites at the facility tested positive for pseudomonas aeruginosa including sink drains, icu sinks, patient hot water blankets, and slush machines.(b)(6) testing found that the pseudamonas aeruginosa found in the patient did not match the tested isolates from the or including the cardioquip device indicating no direct link between the adverse event and the cardioquip device.Cardioquip continues to work with (b)(6) to further the investigation of this event and assist in determining the source of the patient infections.At this time cardioqup has not received the data from the testing performed by (b)(6).If cardioquip is able to obtain the testing results from (b)(6) or if more relevant information regarding this adverse event is identified a follow-up report will be filed.

Event Description

The customer, perfusion manager, reported via conference call with distributor and cardioquip that he was made aware of 3 pseudomonas aeruginosa patient infections and that cardioquip devices in the or had positive cultures of pseudamonas aeruginsoa.He is unaware of the timeframe of the patient infections or the patients' infection site or condition.

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 concern about 3 patient infections; however, upon further investigation by the customer, it was found that the device did not contain the same bacteria that the patients were infected with.

Event Description

The customer reported that there were 3 pseudomonas aeruginosa patient infections.Pseudomonas aeruginosa was found to be present within the cardioquip device, but the customer does not have access to laboratory results or bacterial counts.The customer later reported that the cultures that grew pseudomonas in the or do not match the pseudomonas isolates from the 4 patients that matched.

• 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: 12321691
• MDR Text Key: 267282603
• Report Number: 3007899424-2021-00013
• 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: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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