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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1 Roller Pump

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 Class 2 Device Recall Terumo Advanced Perfusion System 1 Roller Pumpsee related information
Date Initiated by FirmJanuary 10, 2020
Create DateFebruary 07, 2020
Recall Status1 Terminated 3 on May 12, 2020
Recall NumberZ-1108-2020
Recall Event ID 84663
510(K)NumberK172220 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductTerumo 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 move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.
Code Information UDI: 00886799000533; Serial Numbers: 6860 6861 6862 6863 6864 6865 6876 6877 6885 6910 6911 6912 6913 6934 6935 6936 6937 6938 6939 6940 6941 6942 6943 6944 6945 6946 6947 6948 6949 6950 6951 6952 6953 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information ContactTerumo CVS Customer Service
800-521-2818
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionTerumo 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 in Commerce33
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTQ
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