Sarns 9000 Heart-Lung Console

• 3 recalls, same reason

  • Terminated Z-2050-2012 FDA Class II ·initiated 18 Jun 2012
  • Terminated Z-2052-2012 FDA Class II ·initiated 18 Jun 2012
  • Terminated Z-2051-2012 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

• 9 recalls, same reason

  • Terminated Z-2618-2011 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
  • Terminated Z-2621-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2616-2011 FDA Unclassified (pre-2012) ·initiated 3 May 2011
  • Terminated Z-2614-2011 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-2613-2011 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-0296-2009 FDA Unclassified (pre-2012) ·initiated 23 May 2008
  • Terminated Z-0295-2009 FDA Unclassified (pre-2012) ·initiated 23 May 2008

  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.

510(k) Number

K871131 ↗

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

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