Sarns 8000 Modular Perfusion System

• 6 recalls, same reason

  • Terminated Z-0129-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0131-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0128-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0130-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0127-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0126-2013 FDA Class II ·initiated 25 Sep 2012

  Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction

• 6 recalls, same reason

  • Terminated Z-0280-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0283-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0285-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0282-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0281-2013 FDA Class II ·initiated 25 Sep 2012
  • Terminated Z-0284-2013 FDA Class II ·initiated 25 Sep 2012

  Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardio

• • Terminated Z-2218-2012 FDA Class III ·initiated 20 Jun 2012

  During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc

• 6 recalls, same reason

  • Terminated Z-2049-2012 FDA Class II ·initiated 18 Jun 2012
  • Terminated Z-2047-2012 FDA Class II ·initiated 18 Jun 2012
  • Terminated Z-2045-2012 FDA Class II ·initiated 18 Jun 2012
  • Terminated Z-2048-2012 FDA Class II ·initiated 18 Jun 2012
  • Terminated Z-2046-2012 FDA Class II ·initiated 18 Jun 2012
  • Terminated Z-2044-2012 FDA Class II ·initiated 18 Jun 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 expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst

• 4 recalls, same reason

  • Terminated Z-1453-2012 FDA Not yet classified ·initiated 21 Mar 2012
  • Terminated Z-1451-2012 FDA Not yet classified ·initiated 21 Mar 2012
  • Terminated Z-1452-2012 FDA Not yet classified ·initiated 21 Mar 2012
  • Terminated Z-1450-2012 FDA Not yet classified ·initiated 21 Mar 2012

  Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display, or could cause monitor reset, po

• • Terminated Z-0303-2012 FDA Unclassified (pre-2012) ·initiated 21 Oct 2011 ·on shared 510(k) K915183

  Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer.

• 9 recalls, same reason

  • Terminated Z-2613-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2620-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2617-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2614-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2616-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2618-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2621-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2619-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2615-2011 FDA Unclassified (pre-2012) ·initiated 3 May 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 change in the pressure dome's manufacturing process.

• 2 recalls, same reason

  • Terminated Z-0562-2011 FDA Unclassified (pre-2012) ·initiated 2 Nov 2010 ·on shared 510(k) K915183
  • Terminated Z-0563-2011 FDA Unclassified (pre-2012) ·initiated 2 Nov 2010 ·on shared 510(k) K915183

  The system 8000 roller pumps may fail resulting in a persistent pump stop.

• • Terminated Z-2348-2012 FDA Class II ·initiated 12 Aug 2009

  Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav

• 6 recalls, same reason

  • Terminated Z-0241-2007 FDA Unclassified (pre-2012) ·initiated 14 Sep 2006 ·on shared 510(k) K915183
  • Terminated Z-0239-2007 FDA Unclassified (pre-2012) ·initiated 14 Sep 2006 ·on shared 510(k) K915183
  • Terminated Z-0236-2007 FDA Unclassified (pre-2012) ·initiated 14 Sep 2006 ·on shared 510(k) K915183
  • Terminated Z-0237-2007 FDA Unclassified (pre-2012) ·initiated 14 Sep 2006 ·on shared 510(k) K915183
  • Terminated Z-0240-2007 FDA Unclassified (pre-2012) ·initiated 14 Sep 2006 ·on shared 510(k) K915183
  • Terminated Z-0238-2007 FDA Unclassified (pre-2012) ·initiated 14 Sep 2006 ·on shared 510(k) K915183

  The hand crank handle may separate and detach from the unit during use.

• 3 recalls, same reason

  • Terminated Z-1004-2007 FDA Unclassified (pre-2012) ·initiated 1 Jul 2004
  • Terminated Z-1002-2007 FDA Unclassified (pre-2012) ·initiated 1 Jul 2004
  • Terminated Z-1003-2007 FDA Unclassified (pre-2012) ·initiated 1 Jul 2004

  Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K915183 ↗

FDA Product Code

DTQ

Device Class

Class II

Regulation

21 CFR Part 870.4220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Monitor Kits, Blood Level

  Class II

  FDA 510(k) K781145 Active Cleared 27 Jul 1978

• 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System

  Class II

  FDA 510(k) K950739 Active Cleared 17 Nov 1995

• Flexible Arterial Cannulae

  Class II

  FDA 510(k) K771499 Active Cleared 16 Aug 1977

• Battery Operated Flow Rate Computer

  Class II

  FDA 510(k) K760756 Active Cleared 15 Oct 1976

• Centrifugal Pump System Lx/Dx Version

  Class II

  FDA 510(k) K882758 Active Cleared 13 Oct 1988

• Clear Cardioplejia Delivery System

  Class II

  FDA 510(k) K823451 Active Cleared 14 Jan 1983

See all devices from 3M Health Care, Sarns →

• What is the primary function of the Sarns 8000 Modular Perfusion System?

  This device serves as a heart-lung machine console specifically designed to support cardiopulmonary bypass procedures by managing blood flow and monitoring vital parameters during surgery.

• How can the Sarns 8000 system be configured for clinical use?

  The system is built on a modular platform that allows for a base configuration of either four or five pumps. Clinicians can select from various pump head types, including roller or centrifugal options, to meet specific procedural requirements.

• What monitoring capabilities are integrated into the console?

  The system includes dedicated arterial and cardioplegia monitors. These modules are designed to track essential patient data, including temperature, pressure, and time, to assist in the management of the bypass procedure.

• What is the regulatory status of this perfusion system?

  The Sarns 8000 Modular Perfusion System has received FDA 510(k) clearance under K915183, confirming it has been reviewed and determined to be substantially equivalent to existing devices for its intended use.