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Safety Information

Revised: 2 March 2009

Medical Device Safety Issues

Graseby MS-Series Syringe Drivers

Attention
Chief Executives
Risk Managers
Materials Management

Medsafe expects that Graseby MS-Series syringe drivers will be removed from clinical use by 31 December 2009. However should there be exceptional circumstances caused by delays in availability, supply, training, or other issues relating to the replacement pump recommended by DHBNZ - the Alaris AD Syringe Driver - this date may be revised.

Background

In 2007 Medsafe raised safety concerns about the Graseby MS-Series syringe devices with Smiths Medical New Zealand, the supplier of the devices. Subsequent to this Smiths Medical ceased supply of the MS-Series syringe drivers in both New Zealand and Australia in October 2007.

The Syringe Driver Advisory (SDA) Group was formed in January 2008 to facilitate the safe and smooth transition from the Graseby MS-series syringe drivers to alternative syringe drivers. District Health Boards New Zealand (DHBNZ) conducted an evaluation process to determine a suitable replacement for the MS-series syringe driver. At the end of this process the Alaris AD Syringe Driver was identified as a suitable replacement device.

Cardinal Healthcare, suppliers of the Alaris device, have committed to a nationwide roll-out of the new syringe driver.

Current Situation

Now that there are alternatives to the Graseby MS-Series syringe driver which incorporates safety features consistent with modern medical device design, Medsafe recommends that all users of these devices transition to the Alaris syringe driver or an equivalent alternative syringe driver as soon as possible.

To provide clarity for the transition Medsafe has set a date of 31 December 2009 by which time all Graseby MS-Series syringe drivers should be removed from clinical use and replaced. Medsafe will expect users to recall any Graseby MS-Series syringe drivers still in use at this time.

The final date for the transition will only be influenced by delays in availability, supply, training, or other issues relating to the Alaris AD syringe driver. Should any issues arise Medsafe may revise this date.

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority and is a business unit of the Ministry of Health.

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