By Julia Marders, RN, MS
(Originally published April 2004)
A patient was receiving patient-controlled analgesia (PCA) via infusion pump. The nurse awakened the patient to assess pain and, based on the patient's direction; pushed the PCA button to administer pain medication. The patient eventually became unresponsive and died.
What went wrong?
Someone other than the patient pushing the button on a PCA pump, even at the patient's request, is administering PCA by proxy. This well-intentioned "help" can lead to oversedation, opioid toxicity, or death. I Although PCA pumps include dose and time limits to prevent overmedication, the patient's participation is critical to maintain safety. A sleeping or overly sedated patient won't push the button, so the pain medication is unlikely to reach toxic levels. The nurse in this case overrode the patient's control of his medication by waking him and administering additional analgesia.
What precautions can you take?
- Educate yourself and your colleagues about PCA by proxy. Develop and follow guidelines for using PCA pumps.
- Place warning labels "For patient use only" on PCA buttons or equipment.
- Remind patients and visitors that the PCA is for patient use only and that visitors shouldn't push the button even if the patient asks. Educate them about PCA and tell them to notify a nurse if the patient seems overly sleepy.
- If a patient is difficult to arouse or has respiratory depression, assess his airway, breathing, and circulation; initiate basic life support as indicated and have someone notify the primary care provider.
- If a patient is harmed and you believe that improper use or malfunction of a PCA device played a role, notify the person at your facility who's responsible for reporting such problems or submit a voluntary adverse event report through MedWatch by calling 1-800-FDA-1088 or online at http://www.fda.gov/medwatch.
Although you need to support the adverse event-reporting policy of your health care facility, you may voluntarily report a medical device that doesn't perform as intended by calling MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178). The opinions and statements contained in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, coordinates Device Safety.
Julia Marders is a nurse-consultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md.