BEUDAMED
    FDA Recall Terminated

    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.

    Recall: Z-0825-2019 · Initiated December 19, 2018

    Recall

    Recall Number
    Z-0825-2019
    Event Number
    81961
    Firm
    Cincinnati Sub-Zero Products LLC, a Gentherm Company
    FEI Number
    1516825
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 19, 2018
    Terminated
    April 24, 2020
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    Description

    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.

    Reason

    Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.

    Action

    Initial notification letters were sent to customers on 12/19/18 to inform them of the upcoming field action. An additional letter sent to customers on 1/18/19 providing instructions on the correction. The letter identified the affected product, problem and actions to be taken.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The products were distributed to the following foreign countries: Columbia and Taiwan.

    Quantity

    396