Terumo Sarns System 1

Technical Specs

Height

22.6 in

Length

35.2 in

Weight

262 lbs

Width

26.6 in

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Operating rooms
• Procedure rooms
• Interventional suites

Documents & Manuals

• Termo Sarns System 1 brochureBrochure · External
• TermobrochureBrochure · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

• RECALL

  Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.

• RECALL

  During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

• RECALL

  During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

• RECALL

  During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.

• RECALL

  During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and Sarns" Venous Return Cannulae.

• RECALL

  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 pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.

• RECALL

  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, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.

• 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.

• RECALL

  Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.

• RECALL

  Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

• RECALL

  The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

• RECALL

  Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In

• RECALL

  Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.

• RECALL

  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 Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat

• RECALL

  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' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unli

• RECALL

  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) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re

• RECALL

  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 System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu

• RECALL

  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 expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syste

• RECALL

  During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti

• RECALL

  During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the

• RECALL

  During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.

• RECALL

  Terumo Cardiovascular Systems has received one report of minute metal shavings leaking from the Sarns Sternal Saw I System at the point where the saw blade is inserted into the saw handpiece.

• RECALL

  Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.

• RECALL

  Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case.

• RECALL

  The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting

• RECALL

  Terumo Cardiovascular Systems (CVS) has received 19 reports of a circuit breaker for the Terumo Advanced Perfusion System 1 tripping and causing the system to switch to battery back-up power. In two cases, the incident was caused when the circuit breaker came into incidental contact with the base of an IV pole; in others there was no known cause. Terumo CVS' investigation has determined that

• RECALL

  The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation.

• RECALL

  Medical device vent port may be occluded and prevent delivery of priming fluid.

• RECALL

  Medical device component may malfunction and require user intervention during surgical bypass procedures.

• RECALL

  The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.

• RECALL

  The level sensor may not properly couple to the reservoir, resulting in a sensor "not attached" message, an alert or alarm condition, or a failure to detect a low level condition.

• RECALL

  The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.

• RECALL

  A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.

• RECALL

  The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.

• RECALL

  Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.

• RECALL

  The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.

• RECALL

  There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.

• RECALL

  The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.

• RECALL

  Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.

• RECALL

  There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.