Archived - Notice to Hospitals - Association of Syringe Infusion Pumps with a Risk of Delay in Detection of Downstream Occlusion

Starting date:

October 25, 2006

Posting date:

October 25, 2006

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001380

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on Syringe Infusion Pumps

October 25, 2006

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Emergency, Pediatrics, Anaesthesia, Surgery, Intensive Care, Medicine and other involved professional staff and post this NOTICE in your institution.

Subject: Syringe Infusion Pumps - Risk of Delay in Detection of Downstream Occlusion

Health Canada is aware of international reports of delays in occlusion detection associated with the use of syringe pumps and wishes to alert healthcare professionals to this safety information.

Syringe infusion pumps are devices used to provide a continuous intravenous administration of medication. They are mostly used in anaesthesiology, intensive care and emergency medicine to deliver small volumes of highly potent medications. They offer many advantages over larger volumetric infusion pumps such as reduced size, lower cost and ease of operation.

Syringe infusion pumps are typically equipped with a pressure sensor at the syringe pump plunger or drive mechanism as well as an occlusion alarm with several pressure settings. When the internal system pressure surpasses the alarm occlusion threshold pre-selected by the operator, the device will alarm and alert users to a possible occlusion event. Any lag period in the detection of downstream occlusion places the patient at risk of serious injury, possibly from the underdelivery of critical medication or the inadvertent delivery of a bolus dose if the occlusion is not carefully corrected.

Cases reported in the medical literature suggest that delays in detecting an occlusion are often associated with the use of large syringe sizes combined with infusions at low flow rates. The length of tubing used and the compliance of the tubing also appear to play a role in the time required for the system pressure to build up sufficiently to trigger the alarm.

To minimize any delay in detecting an occlusion, Health Canada recommends the following:

• When delivering medications by syringe infusion pumps at low flow rates (i.e. 0.5-2ml/hour), use the smallest possible size of syringe recommended by manufacturer.
• Select the lowest possible occlusion alarm pressure when infusing at low flow rates.
• When using a pump equipped with a pressure monitor indicator, check the pressure regularly. If a steadily increasing pressure level is observed, immediately inspect the flow pathway for kinks, clogged catheters or other possible causes of impeded flow.
• Use the least elastic (lowest compliance) infusion sets compatible with the system to minimize the potential for delays in occlusion detection associated with tube compliance.
• Monitor patients closely and frequently check the syringe pumps to ensure the infusion continues to run, especially with paediatric and critical-care patients. Do not depend solely on the occlusion alarm to provide a timely alert.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using syringe infusion pump should be reported to the marketing authorization holder or to Health Canada at the following address:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Tel: The Inspectorate Hotline 1-800-267-9675

The Reporting Form and Guidelines can be obtained from the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

Email: MHPD_DPSC@hc-sc.gc.ca

Tel: (613) 954-6522

Fax: (613) 952-7738

References:

1. Baxter Corporation's Urgent Device Correction letter Re: Auto Syringe AS50 Infusion Pumps, Product Codes 1M8550 and 1M8550R. March 17, 2006.
2. Donmez C, Araz C, Kayhan Z. Syringe pumps take too long to give occlusion alarm. Paediatr Anaesth 2005;15(4):293-6.
3. Weiss M, Neff T, Gerber A, Fischer J. Impact of infusion line compliance on syringe pump performance. Paediatr Anaesth 2000;10(6):595-9.
4. Kim, DW, Steward DJ. The effect of syringe size on the performance of an infusion pump. Paediatr Anaesth 1999; 9(4):335-7.
5. Weiss M, Hug MI, Neff T, Fischer J. Syringe size and flow rate affect drug delivery from syringe pumps. Can J Anaesth 2000;47(10):929-35.