Oxygenator safety evaluation: a focus on connection grip strength and arterial temperature measurement accuracy.

This report describes the assessment of three specific safety-related specifications in the consideration of an alternate oxygenator; first the grip strength relationship between various oxygenator connectors and SMARxT tubing, second, the grip strength of various biopassive tubings and an isolated SMARxT connector, and finally, the accuracy of the arterial outlet temperature measurement. Grip strength experiments for the connections between the SMARxT tubing and the venous reservoir outlet and the oxygenator venous inlet and oxygenator arterial outlet of the Medtronic Affinity, Sorin Synthesis, Sorin Primox, and Terumo Capiox RX25 oxygenators were performed. In addition we compared the grip strength of polyvinyl chloride, Physio, Trillium, Carmeda, X-Coating, and SMARxT tubing.

Improving cardiopulmonary bypass: does continuous blood gas monitoring have a role to play?

The CDI 500 (Terumo Cardiovascular Systems, Ann Arbor, MI) is an in-line blood gas monitoring device that has been used in clinical practice for over a decade. Few randomized studies have evaluated the value of this device with respect to improved perfusion management. We routinely use automated continuous quality indicator programs to assess perfusion management.

Disconnection of Cobe SMARxT tubing from the venous outlet of the Terumo Capiox SX25RX oxygenator during cardiopulmonary bypass.

The use of surface modified, biocompatible tubing in cardiopulmonary bypass has been reported to decrease the inflammatory responses caused by blood contact with the non endothelial surface of poly vinyl chloride (PVC) tubing. The combination of advances in biocompatible tubing and increased affordability resulted in a change to our cardiopulmonary bypass circuit, with the Terumo Capiox SX25 oxygenator and Cobe PVC tubing being replaced with a Terumo Capiox SX25RX (with X coating) and Cobe SMARxT tubing. Prior to the introduction of the coated oxygenator, no connection problems had been evident.

Accuracy of temperature measurement in the cardiopulmonary bypass circuit.

Oxygenator arterial outlet blood temperature is routinely measured in the cardiopulmonary bypass (CPB) circuit as a surrogate for the temperature of the arterial blood delivered to sensitive organs such as the brain. The aim of this study was to evaluate the accuracy of the temperature thermistors used in the Terumo Capiox SX25 oxygenator and to compare the temperature measured at the outlet of the oxygenator using the Capiox CX*TL Luer Thermistor with temperatures measured at distal sites. Five experimental stages were performed in vitro to achieve this aim.