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    Getinge US Customer Letter HCU 30

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    enea 234
    The manufacturer is recalling all Maquet Heater-Cooler Unit HCU 30 devices due to potential bacterial contamination, including mycobacteria, that could cause infection. Facilities using these devices should immediately discontinue their use, decommission the units, and dispose of them, as the manufacturer has not developed an adequate cleaning protocol. The recall affects all HCU 30 units distributed in the US since December 30, 2004. Recipients are asked to acknowledge receiving the recall notice and provide information on the affected devices at their facility.

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    Getinge US Customer Letter HCU 30

    Uploaded by

    enea 234
    30 views3 pages
    The manufacturer is recalling all Maquet Heater-Cooler Unit HCU 30 devices due to potential bacterial contamination, including mycobacteria, that could cause infection. Facilities using these devices should immediately discontinue their use, decommission the units, and dispose of them, as the manufacturer has not developed an adequate cleaning protocol. The recall affects all HCU 30 units distributed in the US since December 30, 2004. Recipients are asked to acknowledge receiving the recall notice and provide information on the affected devices at their facility.

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    The manufacturer is recalling all Maquet Heater-Cooler Unit HCU 30 devices due to potential bacterial contamination, including mycobacteria, that could cause infection. Facilities using these devices should immediately discontinue their use, decommission the units, and dispose of them, as the manufacturer has not developed an adequate cleaning protocol. The recall affects all HCU 30 units distributed in the US since December 30, 2004. Recipients are asked to acknowledge receiving the recall notice and provide information on the affected devices at their facility.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    30 views3 pages

    Getinge US Customer Letter HCU 30

    Uploaded by

    enea 234
    The manufacturer is recalling all Maquet Heater-Cooler Unit HCU 30 devices due to potential bacterial contamination, including mycobacteria, that could cause infection. Facilities using these devices should immediately discontinue their use, decommission the units, and dispose of them, as the manufacturer has not developed an adequate cleaning protocol. The recall affects all HCU 30 units distributed in the US since December 30, 2004. Recipients are asked to acknowledge receiving the recall notice and provide information on the affected devices at their facility.

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    You are on page 1of 3

    July 14, 2021 via FEDEX

    Urgent Medical Device Recall


    HEATER-COOLER UNIT (HCU 30)
    DISCONTINUE USE OF HEATER-COOLER UNITS

    All Product Distributed Since December 30, 2004

    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.

    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.
    • Online: www.fda.gov/medwatch/report.htm
    • Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-
    1088 to request a reporting form, then complete and return to the address on the pre-
    addressed form
    • Fax: 1-800-FDA-0178
    Page 1 of 3
    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
    online form with digital signature, or 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.

    Sincerely,

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

    Page 2 of 3
    July 14, 2021

    URGENT MEDICAL DEVICE RECALL - Response Form


    EMAIL TO: MCPHCU30.qrc@getinge.com
    or FAX BACK TO: (866) 571-5830

    ADD ACCOUNT#
    [Customer NAME
    STREET ADDRESS
    CITY, STATE, ZIP CODE]

    Please check this box to confirm:


    • You will take action as soon as possible according to instructions, and you will ensure that
    all users of the Maquet Heater-Cooler unit(s) (HCU 30) at this facility have been notified
    accordingly.
    • I acknowledge that I have reviewed and understand the Urgent Medical Device Recall for the
    Maquet Heater-Cooler unit(s) (HCU 30) at this facility.
    • I confirm that Maquet Heater-Cooler unit(s) (HCU 30) will be dispositioned accordingly.

    Please provide the required information and signature below and return this form to Getinge even if
    you no longer have the affected device at your facility.

    List of Affected Maquet Heater-Cooler unit(s) (HCU 30) at your facility


    Item description/Serial # Device on site? Yes/No:

    Facility Representative Information:

    Signature: Date:

    Name: Phone:
    E-Mail Address:
    Title: Department:
    Hospital Name:
    Address, City and State:
    _____________________________________________________________________________
    We have sold/moved our Maquet Heater-Cooler unit(s) (HCU 30) to another facility:
    Circle one YES NO
    If you answered YES above: please provide new facility information below.
    New Facility Name and Address:

    New Facility Contact Name: New Facility Phone #:

    Return the completed form by FAX to (866) 571-5830 or email address;


    MCPHCU30.qrc@getinge.com
    Page 3 of 3

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