Urgent Recall - HCU 30 Heater-Cooler Unit

Urgent Medical Device Recall
HEATER-COOLER UNIT (HCU 30)
DISCONTINUE USE OF HEATER-COOLER UNITS

All Product Distributed Since December 30, 2004HCU-30
PLEASE FORWARD THIS INFORMATION TO ALL USERS, PERFUSIONISTS, AND STAFF WHO MAY USE AND/OR MAINTAIN MAQUET HEATER-COOLER UNITS.
Dear Risk Manager,

The purpose of this letter is to advise our customers that if your facility still has any Heater Cooler Unit HCU 30 units, users should discontinue the use of and dispose of these devices. In 2014, Maquet Cardiopulmonary (“MCP”) had sent a letter notifying all customers of the Heater Cooler Unit HCU 30 that the end of service life for all units was December 31, 2017. At that time, all service and maintenance activities would cease support from Maquet Cardiopulmonary.

HCU 30 Recall Acknowledgement Form

Description of the problem:
The use of heater-cooler devices has been associated with Nontuberculous mycobacteria (NTM) infections in patients. There is a potential for bacterial growth in the water systems.

Maquet Cardiopulmonary has received isolated reports indicating bacterial contamination in the system water of HCU 30 including mycobacterial counts. Maquet Cardiopulmonary has not received any reports that a mycobacterial infection or any other bacterial infection has been caused by a HCU 30 Heater-Cooler Unit in the United States.

Actions to be taken by the Device User:
MCP has not developed a cleaning protocol that meets current concerns and expectations of the FDA. If your facility still has any HCU 30 Units in operation, users should take the unit out of operation at the earliest opportunity and decommission the unit. This action impacts customers in the United States.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.

Please acknowledge receipt of the Urgent Medical Device Recall by completing and returning the enclosed response form. Please either fax the completed form to (866) 571-5830 or send via email to MCPHCU30.qrc@getinge.com.

This recall is being made with the knowledge of the U.S Food and Drug Administration.

We apologize for any inconvenience that this may cause to you or your patients. For any questions, please contact your Getinge sales representative or Getinge Technical Support at (888) 9GETUSA / (888) 943–8872 (option 4, 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Thank you for your cooperation and immediate assistance.

patelsig

Rachana Patel
Regulatory Affairs and Field Action Compliance Specialist
Getinge
45 Barbour Pond Drive
Wayne, NJ 07470
Telephone Number: (973) 709 7412

HCU 30 Recall Acknowledgement Form

Download PDF version of this Customer Letter