BEUDAMED
    FDA Recall Terminated

    Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.

    Recall: Z-2414-2011 · Initiated March 16, 2011

    Recall

    Recall Number
    Z-2414-2011
    Event Number
    58661
    Firm
    Maquet Datascope Corp Cardiac Assist Division
    FEI Number
    3001418283
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 16, 2011
    Posted
    June 13, 2011
    Terminated
    October 25, 2012
    Address
    1300 MacArthur Blvd., Mahwah, NJ, 07430-2052

    Description

    Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.

    Reason

    Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.

    Action

    Maquet sent an Urgent Product Field Correction letter dated March 16, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to note the WARNING in the IABP Operating Instruction. Customers were advised to refer to the IAB Instructions for Use, Section D (Manually inflating and Deflating a Catheter). Section D of the IAB instruction for Use reiterates that an IAB should not remain inactive for more than 30 minutes and also provides detailed instruction on how to keep an IAB active during IABP failure. Customers were advised that their Service Representatiave would arrange to replace their supply which would contain a new fan assembly. Upon completion of the power supply replacement, customers were asked to sign a service repair order to verify satisfactory completion of the work. For technical questions contact Technical Support Department at 1-800-777-4222 and press 4. For scheduling a service visit by a Field Service Representatiave, contact the firm's US Call Center at 1-800-777-4222 and press 3. Maquet issued a press release on June 6, 2011 advising consumers of the issue and that their recall was considered a class one.

    Distribution

    Worldwide Distribution

    Quantity

    885 units