Patient safety alert: Free-flow IV pumps

Use of IV pumps that do not provide protection from free-flow results in serious injuries, including death.

DESCRIPTION OF THE PROBLEM:
The use of IV pumps that do not provide protection from free-flow have repeatedly caused significant patient injuries, including death. These accidents occur in hospital, home care, and long-term care environments. Selected models and brands of IV pumps allow uncontrolled free-flow of solutions into the patient. This occurs after the common practice of removing the IV tubing from the pump mechanism for patient relocation or manipulation or when the IV is temporarily discontinued. Although most pumps sold today have a fail-safe clamping mechanism, older models and less expensive brands may not. In addition, some manufacturers may label their pumps "free-flow protected," but the clamping mechanism works only while the IV tubing/set remains in the device. Continued availability of older unprotected pumps in institutions that have obtained new protected pumps and confusing labeling may contribute to a false sense of security among staff, leading them to believe the pump's design will always protect against free-flow.

SCOPE and SEVERITY:

NCC Medication Error Index		Number of Cases
Category I:	An error occurred that resulted in patient death	7
Category H:	An error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac arrest)	4
Category F:	An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm	4
Category E:	An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm	4
Category D:	An error occurred that resulted in the need for increased patient monitoring but no patient harm	5
Category C:	An error occurred that reached the patient but did not cause patient harm	14

* National Reporting programs used as a source for this data are the USP-ISMP Medication Errors Reporting program, the FDA MedWatch Program, and the JCAHO Sentinel Event Reporting Program.

SUGGESTED ACTIONS:
Health care professionals and health care organizations should consider the following:

Identify all pumps with potential for free-flow errors, including those with confusing labeling.
Sequester/quarantine/phase out the use of unprotected devices.
Petition FDA to withhold/withdraw approval of IV pumps that permit free-flow.
Petition manufacturers to stop production and sale of free-flow pumps.
Continue to report errors associated with the use of IV pumps that do not protect against free-flow so that accurate frequency and severity of these errors can be assessed.

Posted: 07/1999

This information provides notification of situations in which errors may occur. The identification of particular products or brands should not be interpreted as an adverse reflection of the product or manufacturer. The suggestions to avoid medication errors are general and should be properly evaluated before implementation to determine whether they are appropriate for use in particular work environment.