BEUDAMED
    FDA Recall Terminated

    CS 100i Intra-Aortic Balloon Pump

    Recall: Z-2736-2017 · Initiated June 16, 2017

    Recall

    Recall Number
    Z-2736-2017
    Event Number
    77566
    Firm
    Maquet Datascope Corp Cardiac Assist Division
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 16, 2017
    Posted
    June 23, 2017
    Terminated
    November 29, 2019
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    CS 100i Intra-Aortic Balloon Pump

    Reason

    The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

    Action

    Datascope Corp/MAQUET issued a press release on June 16, 2017. Datascope Corp/MAQUET sent an Urgent Product Recall Letter on June 19, 2017, to their customers via FedEx next day delivery service. Pursuant to the WARNINGS section of our CS100i, CS100 or CS300 IABP Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy. Until the service is performed, we recommend the IABP be powered on prior to initiation of therapy to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office. Customers will be instructed to complete and return the attached Medical Device Field Correction Response Form via fax to 1-973-807-9217 or send via email to [email protected]@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. For U.S. customers with technical questions, please contact our Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST

    Distribution

    Worldwide Distribution - (in over 100 countries) US (Nationwide)

    Quantity

    12,319 units total