Cause of Device-Related Incident
Device factors; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Clinical/Biomedical Engineering; Nursing; Pharmacy / IV therapy

Device Factors
Failure of accessory

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Extravasation; Infiltration; Underdose

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Inappropriate reliance on an automated feature

Infusion Pumps [16-495]; Infusion Pumps, Ambulatory [16-491]; Infusion Pumps, General Purpose [13-215]

Infiltration during Infusion Therapy

User Experience Network [Health Devices Jan 1998;27(1):39]


While using an infusion pump to deliver a saline bolus to an infant, our staff noticed swelling and discoloration of the infant's forearm caused by infiltration. The infusion was stopped, and the pump was removed from service for inspection. The pump did not alarm during the infiltration, but we could not detect any problems with the device. The supplier informed us that the device was not intended to detect or prevent infiltration.


Infiltration—also called extravasation—is the extravascular accumulation of a solution being infused. One consequence of infiltration is that it can lead to necrosis; however, the primary consequence is that the patient is denied necessary fluids or medications. Because vital intravenous (IV) medications are frequently delivered to a patient by means of infusion therapy, infiltration can have serious effects on a patient's health.

A number of infiltration incidents have been reported to ECRI implicating all types of infusion pumps. However, infusion pumps typically play only an ancillary role in such incidents, and the belief that the pumps themselves produce infiltration is inaccurate. Rather, the usual causes of infiltration are dislodgment or improper insertion of either a catheter or—in the case of a subcutaneous injection port—a needle. Thus, to avoid problems, staff members should monitor IV sites of patients who are receiving infusions through pumps at least hourly to ensure that catheter or needle dislodgment and subsequent infiltration do not occur.

Another common misconception is that occlusion alarms on infusion pumps will signal infiltration. In fact, pumps will alarm only when downstream pressure reaches a specified value, and elevated pressures resulting from infiltration are typically far lower than occlusion alarm triggering levels. ECRI is not aware of any currently marketed infusion pump that can reliably detect infiltration. We addressed the various approaches to infusion pump pressure detection in Health Devices 18(3-4):106-7, March-April 1989.


  1. During routine hospital training, instruct staff members that infusion pumps do not detect infiltration and that patients receiving infusions through these devices should therefore be supervised closely and IV sites should be assessed hourly.
  2. Inform all clinical engineering personnel that infusion pumps submitted for maintenance following infiltration incidents can be returned to service after routine inspection and documentation.
  3. Instruct clinical engineering personnel to monitor the trends of repair requests that indicate infiltration. If this problem is persistent, additional staff training on avoiding infiltration may be needed.


  • Infusion Pumps [16-495]
  • Infusion Pumps, Ambulatory [16-491]
  • Infusion Pumps, General Purpose [13-215]

Cause of Device-Related Incident

Device factor: Failure of accessory

User error: Inappropriate reliance on an automated feature

Mechanism of Injury or Death

Extravasation; Infiltration; Underdose

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