What is an infusion pump?

Analyzing the risk

Documento realizado con base en la FDA y ECRI Institute
Javier Camacho.

1. Introduction
An external infusion pump is a medical device used to deliver fluids into a patient’s body in a controlled
manner. There are many different types of infusion pumps, which are used for a variety of purposes and in a
variety of environments. Infusion pumps may be capable of delivering fluids in large or small amounts, and
may be used to deliver nutrients or medications – such as insulin or other hormones, antibiotics,
chemotherapy drugs, and pain relievers. Some infusion pumps are designed mainly for stationary use at a
patient’s bedside. Others, called ambulatory infusion pumps, are designed to be portable or wearable.

A number of commonly used infusion pumps are designed for specialized purposes. These include:

• Enteral pump - A pump used to deliver liquid nutrients and medications to a patient’s digestive
tract. More information link https://www.youtube.com/watch?v=v36FoLyiDpQ

Fig. Enteral pump. Alamy Stock Photo

• Patient-controlled analgesia (PCA) pump - A pump used to deliver pain medication, which is
equipped with a feature that allows patients to self-administer a controlled amount of medication,
as needed. More information https://www.youtube.com/watch?v=9iXH0X8PsTY

Fig 3. PCA Pump. https://www.mskcc.org/cancer-care/patient-education/patient-controlled-analgesia-pca

• Insulin pump - A pump typically used to deliver insulin to patients with diabetes. Insulin pumps are
frequently used in the home.
What is an infusion pump? Analyzing the risk
Documento realizado con base en la FDA y ECRI Institute
Javier Camacho.

Infusion pumps may be powered electrically or mechanically. Different pumps operate in different ways. For
example:

• Syringe pump, fluid is held in the reservoir of a syringe, and a moveable piston controls fluid delivery.

Fig 4. Syringe Pump. https://www.bd.com/en-za/our-products/infusion/infusion-devices/alaris-plus-platform-with-guardrails-safety-software/alaris-cc-plus-syringe-

pump-with-guardrails

• Elastomeric pump, fluid is held in a stretchable balloon reservoir, and pressure from the elastic walls
of the balloon drives fluid delivery. The pump will be connected to central venous catheter (CVC).
There are 3 main types of CVCs: tunneled chest catheters, peripherally inserted central catheters
(PICCs), and implanted ports

Fig 5. Elastomeric pump. https://www.mskcc.org/cancer-care/patient-education/continuous-infusion-elastomeric-pump

2. Insulin pumps
Insulin pumps play an important role in modern diabetes treatment. These pumps are typically used to help
maintain blood glucose (BG) levels by delivering rapid-acting insulin through a catheter placed under the skin.
Pumps used for subcutaneous insulin delivery not only provide patients with increased convenience and
flexibility, but also provide the potential for greater dose precision, more reliable insulin action, and relatively
quick dosing adjustments for different lifestyle activities.

While insulin pump technology has helped patients lead a more normal, healthy life, the devices do present
risks (i.e., combination of the probability of occurrence of harm and the severity of that harm2) to the patient
or user of the device. These risks are rooted in the complex technology itself, development and manufacturing
errors, individual differences in physiology and lifestyle, and because the devices are operated by patients
themselves, on a daily (24/7) basis, and in diverse environments.
What is an infusion pump? Analyzing the risk
Documento realizado con base en la FDA y ECRI Institute
Javier Camacho.

Fig 4. Insulin Pum. Fuente: https://www.mountsinai.org/health-library/special-topic/insulin-pumps

Fig5. System architecture of generic insulin infusion pump.

3. Generic Insulin Infusion Pump (GIIP)

Architecture
The GIIP administers insulin to the user via a delivery path, composed of a drug reservoir, a drug delivery
interface, and the infusion set. Along this path, the drug reservoir acts as a built-in storage unit for insulin
that will be monitored and administered. The drug delivery interface represents a segment of concealed
tubing connecting insulin flow from the reservoir to the infusion set. A pump delivery mechanism provides
the force for moving insulin from the pump to the user at a prescribed rate and for a prescribed duration.

The user/patient interacts with the GIIP through the GIIP user interface. The user interface allows the user to
receive information from GIIP output devices and input data/commands through GIIP user input devices. The
creation of a hazardous situation is contingent on certain conditions or combinations of conditions being
realized during operation of the pump. An underdose, for instance, can be caused by air bubbles getting into
the delivery path (air in line) of the pump. The presence of air bubbles can be caused by many factors, such
as design defects, manufacturing flaws, device failures, misconnections, and use errors.
What is an infusion pump? Analyzing the risk
Documento realizado con base en la FDA y ECRI Institute
Javier Camacho.
What is an infusion pump? Analyzing the risk
Documento realizado con base en la FDA y ECRI Institute
Javier Camacho.

4. Examples of Reported Infusion Pump

Problems
Software problems:

• A software error message is displayed, stating that the pump is inoperable. This occurs in the
absence of an identifiable problem.
• The infusion pump interprets a single keystroke as multiple keystrokes (a problem called a “key
bounce”). For example, the user programs an infusion rate of 10 mL/hour, but the device
registers an infusion rate of 100 mL/hour.

Alarm errors:

• The infusion pump fails to generate an audible alarm for a critical problem, such as an occlusion
(e.g., clamped tubing) or the presence of air in the infusion tubing.
• The infusion pump generates an occlusion alarm in the absence of an occlusion.

Inadequate user interface design ("human factors" issues ):

• The design of the infusion pump screen confuses the user, or the infusion pump does not respond
as it should (i.e., with a warning or alarm) when inappropriate data is entered.
• The infusion pump screen doesn’t make clear which units of measurement the user is expected to
enter. For example, the user may enter weight in pounds when the infusion pump requires it in
kilograms.
• Pump labels or components become damaged under routine use. For example, cleaning the pump,
as the user-maintainer believes is acceptable practice, may damage the pump, making it unreliable
for clinical use. Users with long fingernails may damage the print on the pump keys, making them
unreadable.

References.
What is an infusion pump? Analyzing the risk
Documento realizado con base en la FDA y ECRI Institute
Javier Camacho.
Zhang Y, Jones PL, Jetley R. A hazard analysis for a generic insulin infusion pump. J Diabetes Sci Technol. 2010
Mar 1;4(2):263-83. doi: 10.1177/193229681000400207. PMID: 20307387; PMCID: PMC2864162.

https://www.mskcc.org/cancer-care/patient-education/continuous-infusion-elastomeric-pump

https://www.fda.gov/medical-devices/infusion-pumps/infusion-pump-improvement-initiative

https://www.ecri.org/components/HDJournal/Pages/14th_HD_Achievement_Award_Winner_LMBE-and-
VCH.aspx?tab=2