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

Model Number MCH-1000(R)

Device Problems Biofilm coating in Device (1062); Microbial Contamination of Device (2303)

Patient Problems Sepsis (2067); Multiple Organ Failure (3261)

Event Date 03/01/2021

Event Type  Death  

Event Description

Customer reported that the patient developed serratia bacteremia/sepsis after cardiac and renal transplantation, leading to multiorgan failure and transition to comfort care and later expired.As part of the follow-up investigation, the heater-cooler used during the surgery was examined.During the inspection, it was noted that the tubing inside the machine has extensive buildup of biofilm.It is unknown whether this contributed to the infection.

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.A patient developed serratia bacteremia/sepsis after surgery, leading to multiorgan failure and later expired.The device was inspected by the hospital, and it was discovered that the tubing inside the unit had a buildup of biofilm.During the investigation, the bacteria found in the device did not match the bacteria that caused the patient's infection.The source of the bacteria is still unknown; however, during a discussion with a representative of the hospital, it was mentioned that routine maintenance according to the ifu was not being adequately performed.

• 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: 14739225
• MDR Text Key: 294373698
• Report Number: 3007899424-2022-00015
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MCH-1000(R)
• 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: 03/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female