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U.S. Department of Health and Human Services

Case Study 1 – Human Factors

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Jane J., a 31-year-old Caucasian female, was admitted to the hospital in early labor on June 2. Her due date was June 4. Her two previous pregnancies had been uneventful. Later that evening at the hospital, Jane’s doctor ordered a drug to induce labor. The night nurse used an XYZ Devices IV pump to deliver the medication at 2 mL/hour. After the 7 a.m. shift change, the day nurse started a new bag of the drug to induce labor at approximately 7:44 a.m. She hung the new bag of 500mL Lactated Ringers (LR) containing 30 units of the labor-inducing drug. She used the same pump and tubing set as the night before and set it to flow again at 2 mL/hour. She stayed with the patient for the first few minutes and then left the room to care for other patients.

Approximately 15 minutes later, the patient called out in pain for the nurse. When the nurse entered the room, she noticed the IV bag was empty and immediately stopped the pump and clamped the line. The pump was removed from the room and the patient was treated. These quick actions avoided the need for an emergency caesarean section.

The hospital risk manager, Ms. Harris, examined the pump approximately 1 hour after the incident and found the pump door was closed and the IV tubing was still in place. It appeared the total dose infused over about 15 minutes rather than 15 hours, although the pump settings had been entered accurately. Ms. Harris also met with the night nurse and learned that the infusion was discontinued at 5 a.m. as directed and the IV tubing was clamped off and left in the pump. The day nurse reported that she had not inspected the tubing behind the pump door but had turned on the pump, entered the correct infusion rate, and pushed the start button. She insisted there was no audible or display alarm to alert her to a problem with the tubing or the infusion.

The hospital’s biomedical engineering staff also examined the pump, finding no mechanical defects or physical problems. However, they did notice that the tubing was not running through the designated track path in the pump. Ms. Harris noted that this was the fourth documented case of a free-flow event with that brand of infusion pump, despite its relatively recent introduction to the hospital. XYZ Devices’ personnel had trained hospital staff on its use the previous year.

A. Patient Information


3. Sex

4. Weight

or

B. Adverse Effects, Product Problem or Error

1. Check all that apply: (?HelpUseful TipThe HIPAA Privacy Rule specifically permits pharmacists, physicians, nurses, or hospitals (i.e. covered entities) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.)


C. Product Availability

Product Available for Evaluation? (Do not send product to FDA)

D. Suspect Product(s)

E. Suspect Device


5. Operator of Device


8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?

F. Other (Concomitant) Medical Products

G. Reporter



2. Health Professional?
4. Also Reported to:
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