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

Model Number MCH-1000 REFRIDGERATION MODULE

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/21/2019

Event Type  malfunction  

Event Description

Customer reports that the device has had two water samples taken for mycobacterium testing after a patient had repeating trips to the or with a sternal wound which is believed to be caused by mycobacterium fortuitum.They have not identified that any on device was used on said patient, and tested the water for posterity.One sample was taken on (b)(6) 2019, which resulted in a positive identification of mycobacterium chelonae and was taken by a swab from the device's water tank drain.The second sample was taken on (b)(6) 2019, and tested positive for an unknown mycobacterium pending identification.The customer states that cleaning procedures are performed twice a week, using 8.25% clorox bleach.The customer's water source and other water-based devices were tested and came back negative.The unit is also reported as having a leak or condensation issue which they would like addressed.

Manufacturer Narrative

Bacterial contamination reported.

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 device under investigation is a refrigeration module (12160188), and as described in the initial investigation, the contamination failure is associated with a water tank of an mch-1000.The reported event referenced device contamination of the water tested from the tank drain, which does not pertain to contamination of a refrigeration module.Therefore, device failure identified is not associated with the device listed in the report (12160188).The reported event did not result in a connection between the mch-1000 water tank that was tested for bacterial contamination or the mch refrigeration module identified as the device associated with this report.Therefore, there is no product problem to be reported with this device.

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: 13591511
• MDR Text Key: 286532317
• Report Number: 3007899424-2022-00005
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCH-1000 REFRIDGERATION MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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
• Patient Outcome(s): Required Intervention