Medical device manufacturer, Terumo Cardiovascular Systems (CVS) Corporation has issued a field safety notice concerning its Sarns Disposable Centrifugal Pumps.

The manufacturer has received complaints of Sarns Disposable Centrifugal Pumps leaking due to a crack in the molded separator.

The manufacturer's investigation determined that two factors must be present to cause a leak in the molded separator:

• Degradation in the strength of the separator material: Exposure to extremely low temperatures can degrade the strength of the separator's polycarbonate resin.
• Contraction of two dissimilar materials: The polycarbonate separator and stainless steel bearing can contract at different rates while exposed to extremely low temperatures, potentially causing the white separator to crack. Product was exposed to these temperatures in the course of transport during an unusually harsh winter. These temperatures were outside a clinically relevant operating range.

If a pump leaks during priming, the centrifugal pump can be changed out prior to initiating cardiopulmonary bypass (CPB) with no delays in the surgical procedure.

If a centrifugal pump leaks while the patient is on CPB, the manufacturer advises user to follow the instructions for use (IFU) and replace the centrifugal pump. In any time a centrifugal pump fails when being used as an arterial pump, arterial flow to the patient is interrupted during the change-out procedure. In addition, a stopped centrifugal pump can result in retrograde flow from the patient to the circuit.

Potential patient impact includes air embolism, blood loss, infection and/or an interruption in the cardiopulmonary bypass support for an indeterminate amount of time.

In addition, replacing a centrifugal pump during CPB necessitates that the replacement device connections be made with wet connections which do not have the same security as a dry connection. This can increase the risk of a tubing disconnection.

The manufacturer advises users to stop using Sarns Disposable Centrifugal Pumps from the affected single, sterile centrifugal pump lots or Cardiovascular Procedure Kit lots. The manufacturer will also replace or credit unused affected centrifugal pumps.

According to the local supplier, the affected products were NOT distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 25 April 2014