MAUDE Adverse Event Report: CARDIOQUIP MODULAR COOLER-HEATER (MCH); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

In (b)(6) 2020, our facility was notified by the fda that patients from one organization had experienced ntm infections (m abscessus) after heart surgery where the cardioquip heater cooler devices were used.This prompted our organization to send samples from our machines to an outside lab for testing.5/8 cardioquip devices came back positive for ntm.Lab results available.We have not identified any related infections at this time.Upon receiving these results, a group convened and learned the following: testing of our 8 devices revealed 5 of 8 machines contaminated with ntm, no known infections with ecmo patients and use of cardioquip in the literature, risk for infection is very low, but not zero.We only use the device to heat-not to cool.Standard work for machine use and cleaning very rigorous, however design of machine is flawed.Next steps include: continued use of the three machines that tested negative, since there is no acceptable substitute.All three will be re-tested, report to fda, connect with the manufacturer, potential retrospective review of 200 ecmo patients.

• Brand Name: MODULAR COOLER-HEATER (MCH)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP; 8422 calibration ct; college station TX 77845
• MDR Report Key: 10940079
• MDR Text Key: 219328325
• Report Number: 10940079
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCH-1000
• Device Lot Number: 537766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1