Issue |
J Extra Corpor Technol
Volume 20, 1988
Proceedings of AmSECT’s 26th International Conference
|
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Page(s) | 41 - 43 | |
DOI | https://doi.org/10.1051/ject/198820S041 | |
Published online | 25 August 2023 |
Original Article
Clinical Evaluation of a New Pump Interface Module (PIM) Safety Device
University of Colorado Health Science Center, Denver, Colorado
* Direct communications to: Susan P. Tornabene C.C.P., Department of Cardiothoracic Surgery, Box C10, 4200 E. Ninth Avenue, Denver, CO 80262
The Pump Interface Module (PIM) is a new safety device intended to be used in conjunction with a Cobe Air Emboli Protection System (AEPS) and a roller or centrifugal pump. The PIM is a relay device that upon receiving an alarm signal from the AEPS, interrupts line voltage, thus stopping the arterial pump. The purpose of this clinical trial was to verify the utility and user advantages of the PIM when employed with a variety of pumps. The study first involved ex vivo tests using the bovine model. These tests looked at different AEPS positioning, different blood flows, and simulation of a variety of clinical conditions. The clinical study evaluated the PIM using five different types of pumps during 160 open heart procedures. The pumps used were a Cinco (n = 28), Sarns 5000 (n = 47), Sarns 7000 (n = 33), Biomedicus 520 (n = 27), and Biomedicus 540 (n = 25). In all instances the PIM immediately stopped the arterial pump when an alarm signal was received from the AEPS system. The PIM is an effective and practical safety device for use with the tested pumps.
© 1988 AMSECT
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