Local anesthetic infusion pump systems adverse events reported to the Food and Drug Administration.

THE purpose of this report is to characterize adverse event reports on continuous direct local anesthetic infusion into surgical wounds using infusion pump systems devised for this purpose. These pump systems typically consist of disposable, nonelectrical pumps or electromechanical pumps that deliver a continuous infusion at controlled rates for a specified duration of time. Postoperative pain may be managed by continuous direct infusion of anesthetic into a surgical wound. This technique is reportedly used in a variety of surgeries, e.g., inguinal hernia repair, upper abdominal surgery, laparoscopic nephrectomy, cholecystectomy, knee arthroplasty, and shoulder and gynecologic operative laparoscopy. Infusion pump systems for anesthetic wound perfusion are regulated by the U.S. Food and Drug Administration (FDA) as medical devices. The FDA monitors the performance of regulated medical devices via a passive surveillance system. Adverse events during direct local anesthetic infusion into surgical wounds, with an infusion pump system, have been reported to the FDA. These reports involve adverse events reported for surgeries performed at a variety of surgical sites, including orthopedic, gastrointestinal, podiatric, and others. Complications encountered with these infusion pump systems include tissue necrosis, surgical wound infection, and cellulitis. Following are examples of cases reported to the FDA and a summary of 40 injuries that occurred using direct local anesthetic infusion pump systems. These reports may represent sentinel events, i.e., an early warning that is representative of a problem that is widespread, or alternatively, these may be isolated incidents.