Recall Z-1978-2013— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1978-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-26

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2013-07-26, terminated 2017-02-07. It names one FDA 510(k) clearance: K022947. Product: 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.. Reason: TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-07-26
Terminated: 2017-02-07
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K022947 — ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCHTerumo Cardiovascular Systems Corp.·cleared 2003-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.

Reason for recall

TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.