Dynamic List Information
Dynamic List Data
Title
Luer Misconnection Adverse Events
Memo #
13-14-ALL
Posting Date
2013-03-08
Fiscal Year
2013
Title
Luer Misconnections continue to result in adverse events and deaths – Luer connectors easily link many medical components, accessories, and delivery systems. Clinicians, in any type of provider or supplier setting, can mistakenly connect the wrong devices and deliver substances through the wrong route. Despite numerous alerts and warnings, a patient’s blood pressure tubing was recently misconnected to an intravenous (IV) line in an ambulatory surgery center (ASC) resulting in a patient death.
• Adverse Event Complaint Investigation: During a complaint investigation for an adverse event involving delivery of an incorrect substance or utilization of an incorrect delivery route, surveyors must be alert to whether the event involved misconnection of a Luer device. If so, surveyors must determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse event.
• Facility Reporting to Food & Drug Administration (FDA): Surveyors should encourage health care facilities to report problems with Luer misconnections to the FDA, even if no adverse event occurred.
• Adverse Event Complaint Investigation: During a complaint investigation for an adverse event involving delivery of an incorrect substance or utilization of an incorrect delivery route, surveyors must be alert to whether the event involved misconnection of a Luer device. If so, surveyors must determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse event.
• Facility Reporting to Food & Drug Administration (FDA): Surveyors should encourage health care facilities to report problems with Luer misconnections to the FDA, even if no adverse event occurred.