Power Injection of MRI and CT Contrast Media
MedSun: Newsletter #33, February 2009

FDA has received reports discussing vascular access device rupture under high pressure. The ruptured devices included central venous catheters, implanted ports, extension tubing and I.V. administration sets. Ruptures occur when the injection pressure is too great for the vascular access device to withstand. The articles found in the Additional Information section below have been collected from a variety of sources to provide you with information on this topic, as well as with recommendations on how to prevent these errors.

A recent MedSun report (also featured in this month’s Highlighted Report section) addresses this very issue. In this reported event, the I.V. tubing split from internal pressure upon introduction of power injection contrast media.

Additional Information:

Power Injectors Put I.V. Lines Under Pressure. Melissa Eakle, MSN and Susan Lange, MPH. Medical Device Safety.

http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/UCM064667.pdf

Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection. Medical Device Safety.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070193.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun