Medical device manufacturer, Teleflex, has issued a medical device safety alert concerning its Arrow AutoCAT 2 Intra-Aortic Balloon Pump and Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) [Product Codes: IAP-0400, IAP-0400E, IAP-0500, IAP-0500E, IAP-0500I, IAP-0500J, IAP-0500NL. IAP-0535, IAP-0700, IAP-0701].
The manufacturer has initiated a voluntary Field Safety Corrective Action for the affected IABPs, which are intra-aortic balloon pump systems that provide temporary circulatory support for patients with a variety of acute and sub-acute circulatory conditions.
A potential issue with a Component (i.e. motor driver connector) within the affected IABPs may impact the ability of the devices to operate. The Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for "System Error 3" and "High Baseline" presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP. The potential for this issue to occur is related to aging of the Component; therefore, IABPs will be addressed by age, and execution will consist of immediate, subsequent, and long-term corrective actions.
According to the manufacturer, there have been no reports of a sudden stoppage without a prior "System Error 3" or "High Baseline" alarm indicative of deterioration of the Component. However, the absence of prior alarms does not ensure that the IABP is not affected by this problem. If a patient requires circulatory support with an IABP and the device does not work, or if therapy abruptly stops during use without a replacement IABP available, device failure may result in immediate and serious health consequences, including death.
The manufacturer recommends against using an IABP for ground or air transport between medical facilities pending implementation of the Long Term Action. For IABP use during ground or air transport prior to implementation of the Long Term Action, it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered.
The manufacturer will contact each impacted facility to schedule inspection and servicing of all IABP units that contain the internal Component. The inspection and servicing will be performed onsite at facilities, for all IABP units.
The manufacturer has initiated a new design of the motor connector Component. The manufacturer will replace the existing Component with the new design in all IABPs at all facilities.
At the time the proposed modification is ready for implementation, a subsequent notification will be sent to all affected users to schedule and commence replacement of the Component. Any facilities, which have a previously serviced IABP under the scope of the Medical Device Correction, will be revisited to install the new design of the motor connector Component in a subsequent visit from the manufacturer.
The affected users are required to follow the instructions as stated in the Field Safety Notice until complete implementation of the Long Term Action.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 May 2020