Part 6: Pitocin Pump Case Study

This post is Part 6 of a series based on Nursine Jackson’s article, “What about that Device Data?”.

Pitocin Pump Case Study

The labor nurse’s medical record entries on the flowsheet documented a completely benign course of labor in which she started the Pitocin infusion at 09:39 and kept the Pitocin infusing at 2 mu/min through delivery at 12:41. Inconsistent with the nursing flowsheet’s representation, the electronic fetal monitoring tracing showed increasingly serious tachysystole with poor resting tone between contractions more than an hour prior to 09:39, and a fetus who became increasingly intolerant of this harsh environment. The inconsistencies made the attorney’s team suspicious that the Pitocin infusion reported may not have been accurate.

In discovery, the plaintiff’s advocates learned that the Pitocin was delivered using an infusion pump made by Alaris. A simple Google search provided links to user manuals, training videos, tip sheets, an FDA alert about the Alaris Pump Module, and other useful sources of information for depositions and case development[1]. They learned that this infusion pump recorded data and was capable of generating a robust audit trail of its activities.

After a motion to compel production of the device audit trail, the defendant hospital reluctantly provided the audit trail from the Pitocin pump, but only after insisting for a year that the data was overwritten and unavailable. The following table represents only a few relevant columns from the audit trail generated from data collected by the infusion device.

When comparing the information documented by this audit trail to the labor nurse’s entries on the flowsheet, the plaintiff’s team saw that her entries to the flowsheet were incongruous. The device data was more credible because the rates of increasing Pitocin infusion per the pump’s log were consistent with the timing of increasing uterine hyperstimulation documented by the fetal monitor tracings.

In the next round of discovery, the plaintiff’s team obtained the audit trail of the nursing flowsheet. The audit trail showed the exact time the nurse entered data into the flowsheets versus the times displayed on the flowsheet representing the timing of events. The flowsheet’s audit trail illustrated that the nurse created the entire flowsheet many hours after the complicated delivery of a severely depressed baby. For hours, days and months after the event, this nurse accessed the EMR numerous times and further modified the record in a self-serving manner.

Subsequently, the attorney obtained evidence from the labor nurse’s cell phone. This particular hospital allows nurses to BYOD (Bring Your Own Device). The nurse had a hospital approved HIPAA compliant app that stored the phone data.[2] The phone log showed a long series of texts and a prolonged phone call during our client’s last hours of labor, a labor ending with a baby who was severely depressed after being distressed for hours due to secondary to uterine hyperstimulation.

The medical story based on eDiscovery from the Pitocin pump device, the audit trail from the labor flowsheet, and data from the nurse’s cell phone told a distinctly different story from the medical records, and illustrated serious negligence resulting from distracted nursing.

Stay tuned for Part 7 of this series, “Telemedicine Consults and Monitoring”.

[1] Google search for search terms “Alaris infusion pump”: https://www.google.com/search?q=alaris+infusion+pump&rlz=1C1CHBF_enUS842US842&oq=alaris+infusion+pump&aqs=chrome..69i57j0l5.5422j0j7&sourceid=chrome&ie=UTF-8 y.

[2] Laigaie, B & Geary, AR. (2017).HIPAA Compliance in the Smartphone Age. AAOE Practice Management. https://www.aao.org/practice-management/article/hipaa-compliance-in-smartphone-age”.