# K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Mar 20, 2003 after 196 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 150 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915183 (1992). 5 ancestors in all.
26 later devices descend from it; 6 cite it directly.
3 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871131: Sarns 9000 Heart-Lung Console, 3M Health Care, Sarns (1987) Summary page 1.
- K915183: Sarns 8000 Modular Perfusion System, 3M Health Care, Sarns (1992) Summary page 1.
- K953901: Sarns 800  Roller Pump, 3M Health Care, Sarns (1996) Summary page 1.
- K953904: Sarns 9000 Universal Roller Pump, 3M Health Care, Ltd. (1996) Summary page 1.
- K950739: 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System, 3M Health Care, Sarns (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K935978: Delphin II/Stand-Alone Centrifugal Module. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K052555: Medtronic Performer TM CPB, Model R51, PCPB (2006), 8 descendants of its own
- K131041: Advanced Perfusion System 1 (2014), 6 descendants of its own
- K070286: Bio-Console, Model 560 (2007), 6 descendants of its own
- K151349: Advanced Perfusion System 1 (2015), 5 descendants of its own
- K090006: Lifebridge B2T, Model 7001 (2009), 5 descendants of its own

## Recalls of this device
- May 1, 2015 · Class II · Z-1687-2015: Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased appro
- May 1, 2015 · Class II · Z-1688-2015: Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased appro
- Jun 17, 2014 · Class II · Z-2019-2014: An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
- Jun 17, 2014 · Class II · Z-2018-2014: An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
- Jul 26, 2013 · Class II · Z-1974-2013: Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance,
- Jul 26, 2013 · Class II · Z-1969-2013: The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal
- Jul 26, 2013 · Class II · Z-1978-2013: 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 pres
- Jul 26, 2013 · Class II · Z-1973-2013: Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance,
- Jul 26, 2013 · Class II · Z-1968-2013: The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal
- Jul 26, 2013 · Class II · Z-1977-2013: 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 pres
- Nov 14, 2012 · Class II · Z-0435-2013: Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank an
- Nov 14, 2012 · Class II · Z-0436-2013: Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank an
- Sep 20, 2012 · Class II · Z-2449-2012: Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifu
- Sep 10, 2012 · Class II · Z-2443-2012: Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigatio
- Jul 26, 2012 · Class II · Z-2177-2012: Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modu
- Jul 26, 2012 · Class II · Z-2178-2012: Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modu
- Jul 26, 2012 · Class II · Z-2233-2012: Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion 
- Jul 26, 2012 · Class II · Z-2232-2012: Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion 
- Jul 26, 2012 · Class II · Z-2231-2012: Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion 
- Jul 26, 2012 · Class II · Z-2230-2012: Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion 
- Jun 25, 2012 · Class II · Z-1969-2012: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with
- Jun 25, 2012 · Class II · Z-1971-2012: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and wou
- Jun 25, 2012 · Class II · Z-1970-2012: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and wou
- Jun 25, 2012 · Class II · Z-1968-2012: Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with
- Jun 22, 2012 · Class II · Z-1962-2012: Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty a
- Jun 22, 2012 · Class II · Z-2055-2012: Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of
- Jun 22, 2012 · Class II · Z-1958-2012: Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioni
- Jun 22, 2012 · Class II · Z-2056-2012: Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of
- Jun 22, 2012 · Class II · Z-1957-2012: Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioni
- Jun 22, 2012 · Class II · Z-1966-2012: Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery 
- Jun 22, 2012 · Class II · Z-1963-2012: Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty a
- Jun 22, 2012 · Class II · Z-1965-2012: Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery 
- Jun 22, 2012 · Class II · Z-1964-2012: Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty a
- Jun 21, 2012 · Class II · Z-2021-2012: Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascu
- Jun 21, 2012 · Class II · Z-2020-2012: Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascu
- Jun 21, 2012 · Class II · Z-2010-2012: Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues t
- Jun 21, 2012 · Class II · Z-2009-2012: Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues t
- Jun 18, 2012 · Class II · Z-2042-2012: Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were express
- Jun 18, 2012 · Class II · Z-2043-2012: Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were express
- Mar 16, 2012 · Not classified · Z-1320-2012: Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an 
- Mar 16, 2012 · Not classified · Z-1321-2012: Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an 
- Jan 13, 2012 · Not classified · Z-0839-2012: Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and th
- Jan 13, 2012 · Not classified · Z-0840-2012: Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and th
- Nov 10, 2011 · Not classified · Z-0301-2012: Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance 
- Nov 10, 2011 · Not classified · Z-0302-2012: Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance 
- Nov 10, 2011 · Not classified · Z-0300-2012: Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance 
- Nov 8, 2011 · Not classified · Z-0299-2012: 1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion S
- Nov 8, 2011 · Not classified · Z-0298-2012: 1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion S
- May 3, 2011 · Not classified · Z-2613-2011: The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a ch
- May 3, 2011 · Not classified · Z-2620-2011: The firm has recieved complaints regarding 35 pressure monitoring kits in which the membrane in the kit separated form the pressure dome housing. The firm determined that the defect was caused by a ch

## Indications for use
The TerumoB Advanced Perfusion System 1 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 professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

Source page: https://510kreport.com/device/K022947
Methodology: https://510kreport.com/methodology