An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. Infusion pumps are in widespread use in clinical settings such as hospitals, nursing homes, and in the home. Because infusion pumps are frequently used to administer critical fluids, including high-risk medications, pump failures can have significant implications for patient safety.
As I was writing up Hospira’s Class I recall of its Symbiq Infusion Systems on my laptop for the November 5, 2012, Scalpel Weekly News. I looked up from my keyboard and checked the serial number on the infusion pump to which I was hooked up. Yes, I was receiving my monthly Actemra (tocilizumab) infusion on a recalled infusion pump! The Symbiq Infusion System suffered from a software problem, one of the most common types of reported problems.
Over the past several years, significant safety issues related to infusion pumps have come to the FDA’s attention. These issues can compromise the safe use of external infusion pumps and lead to over- or under-infusion, missed treatments, or delayed therapy. From 2005 through 2009, the FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths. Reported problems involving infusion pumps included (1) software problems; (2) alarm errors; (3) inadequate user interface design; (4) broken components; (5) battery failures; and (6) fire, sparks, charring, or shocks. These adverse event reports and device recalls have not been isolated to a specific manufacturer, type of infusion pump, or use environment.
The FDA recently updated its report on infusion pump failures. The updated report includes sections on each of the six categories of reported problems involving these pumps. The section on software problems, like the problem with the infusion pump I was hooked up to, explained that software problems include error messages of unknown origin and the software’s misinterpretation of user input. For example, a software error message is displayed, stating that the pump is inoperable. This occurs in the absence of an identifiable problem. Alternatively, an example of misinterpretation of input is when 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.
The Symbiq Infusion System was recalled because the infusion pump LCD touch screens sometimes did not respond to user’s selections, resulting in users possibly experiencing a delayed response and/or the screen registering a different value from the value selected by the user. Failure of the touch screen to respond properly to user input could potentially result in a delay or interruption in therapy, or over- or under-delivery of medication if the user confirms the incorrect values displayed on the pump’s confirmation screen prior to starting the infusion.
When it comes to litigating infusion pump product liability, the issue becomes was the error caused by the infusion pump or by user error. My infusion pump’s software problem provides an excellent example of a combination of causes. The software may register a different value from the value selected by the user – a software problem. However, the risk to the patient only happens if the user confirms the incorrect values displayed on the pump’s confirmation screen prior to starting the infusion. But for the user’s error, there would be no risk to the patient.
The wonderful nurses at my infusion center graciously double checked the settings on my infusion pump. They confirmed that I was getting the correct dose at the correct rate. I finished writing your Scalpel Weekly News without incident.
See the FDA Report on Infusion Pumps.
By Sarah Kelman, JD, and the experts and editors at Medical Law Perspectives.
For more details, see the Scalpel Weekly News, December 15, 2014.
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See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication