Sensation Plus 8Fr. 50cc IAB with Accessories, US Only

Description of Event or Problem

During an Emergency Support Program call, the customer reported a Fiber-Optic Sensor Failure alarm on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) supporting a patient with a Sensation Plus 50cc Intra-Aortic Balloon catheter. Troubleshooting, including disconnecting and reconnecting the fiber-optic cable, was unsuccessful; the customer was instructed to disconnect the fiber-optic cable and continue therapy using the transduced inner lumen arterial pressure source, which was already connected and zeroed. No harm was reported. No further assistance was required. The customer requested an IAB catheter return kit. A return kit was sent, but it later returned to the manufacturer without the catheter.

Additional Manufacturer Narrative

E1 - Event Site Name: (b)(6) MEDICAL CENTER.Upon completion of the investigation into this event a follow up report will be submitted.