Recall Z-1108-2020 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to
| Date | Jan 10, 2020 |
| Status | Terminated |
| Reason | 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 this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage. |
| Root cause | Nonconforming Material/Component |
| Action | Terumo began notifying customers via telephone to schedule the repairs on 1/2/20. Urgent Medical Device Correction notification letters dated 1/6/20 were sent to customers. |
| Quantity | 33 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CT, FL, LA, MA, MI, NY, and TX. Countries of Hong Kong, India, South Korea, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172220 | Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation, Aug 17, 2017 |