Gemini Pc-1, Pc-2, Pc-2TX, Pc-4, Signature Edition Infusion Pump (Se), Medsystem III Infusion (Msiii), Medsystem Patient C

• 3 recalls, same reason

  • Ongoing Z-1360-2020 FDA Class I ·initiated 4 Feb 2020
  • Ongoing Z-1362-2020 FDA Class I ·initiated 4 Feb 2020
  • Ongoing Z-1361-2020 FDA Class I ·initiated 4 Feb 2020

  1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

• • Terminated Z-1794-2009 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009

  There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. This notification is to reinforce the importance of inspection of IUI connectors prior

• • Terminated Z-1791-2009 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009

  Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warning message on the user interface of the Alaris PC unit when used in conjunction with the Alaris PCA module. When the Alaris PC unit detects a programmed infusion for the Alaris PCA module that exceed

• • Terminated Z-1790-2009 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009

  There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, an

• • Terminated Z-1237-2009 FDA Unclassified (pre-2012) ·initiated 4 Mar 2009

  The Alaris PCA module can potentially infuse above or below the intended infusion dose.

• • Terminated Z-1710-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the Alaris Pump module ("Pump module"). The user will be required to replace the affected module.

• • Terminated Z-1712-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module ("Syringe module") and Alaris PCA module ("PCA module") for modules manufactured on or before October 4, 2005. The user will be required to re

• • Terminated Z-1711-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules (manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March

• • Terminated Z-1484-06 FDA Unclassified (pre-2012) ·initiated 10 Aug 2006

  This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce.

• • Terminated Z-0568-05 FDA Unclassified (pre-2012) ·initiated 10 Nov 2004

  The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.

510(k) Number

K012383 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Variable Pressure Syringe Pump

  Class II

  FDA 510(k) K974332 Active Cleared 29 Dec 1998

• Medley Syringe Pump Module System, Model 8110 Open recall

  Class II

  FDA 510(k) K023264 Active Cleared 19 Dec 2002

• A-Line Aep Monitor

  Class II

  FDA 510(k) K010965 Active Cleared 27 Jun 2001

• Medley ETCO2 Module (Includes Accessories), Model 8300

  Class II

  FDA 510(k) K031741 Active Cleared 9 Feb 2004

• Medley SPO2 Module, Model 8210 & SPO2 Sensors & Cable

  Class II

  FDA 510(k) K022677 Active Cleared 11 Sep 2002

• Alaris Medical Infusion System Administration Sets Open recall

  Class II

  FDA 510(k) K022209 Active Cleared 6 Aug 2002

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