Medical device manufacturer, Terumo Cardiovascular Systems, has issued a medical device safety alert concerning its Terumo Advanced Perfusion System 1 – 4 Inch and 6 Inch Roller Pump Shafts. The affected products are identified as follows:
The manufacturer identified a potential failure, which could occur with specific Terumo System 1 roller pumps. These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in the condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
If the pump shaft failure should occur and is detected while supporting a patient on cardiopulmonary bypass, pumps tested by the manufacturer exhibiting the failure mode were found to run for a minimum of six hours while running in both continuous and pulsatile modes.
While in the failure mode condition, the pump shaft will still be able to rotate freely, the perfusion tubing can still be removed from the pump race and the hand crank can be used to continue flow while considering additional mitigations.
According to the manufacturer, there have been six user complaints related to the issue. All failures were detected prior to the initiation of cardiopulmonary bypass. There have been no reported illnesses or injuries as a result of the issue.
The patient risks associated with the failure mode involving the shearing of the thread on the pump shaft are dependent on the timing of the failure mode, the assigned functionality of the roller pump and the user's response to the atypical noise being generated by the roller pump. The user's response will be in part predicated on when the noise becomes known, during initial hardware set up, pre-operatively, or during the case. The worst-case potential hazard is a pump stop involving the arterial roller pump or cardioplegia roller pump during cardiopulmonary bypass. The interruption of cardiopulmonary support may require a pump changeout during case.
The manufacturer will execute a field correction to replace the affected roller pump shafts. The manufacturer recommends that users continue using the affected products while waiting for the correction.
According to the local supplier, the affected product is NOT distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 17 January 2020