Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database.

To characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. We conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST). From a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST. Malfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

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© 2020 Teames et al.

Déclaration de conflit d'intérêts

Richard Teames is a paid consultant for Pacira BioSciences, Inc., has previously served as a consultant for Sonosite Fujifilm and Halyard; and reports non-financial support from Pacira BioSciences, Inc., during the conduct of the study; and personal fees from Avanos, Pacira BioSciences, Inc. and Sonosite/Fujifilm, outside the submitted work. Andrew Joyce and Catherine Vick are principals at Venebio Group and served as paid consultants to Pacira BioSciences, Inc. for this study. Andrew Joyce reports personal fees from Pacira Biosciences, Inc., during the conduct of the study. Richard Scranton is a former employee of Pacira BioSciences, Inc. and is now a paid consultant; and reports being a consultant and prior officer of Pacira BioSciences, Inc., during the conduct of the study. Catherine Vick reports being a principal minority owner with Venebio Group: our business was contracted by Pacira BioSciences, Inc. to participate in study design, conduct data management and analyses, and participate in manuscript preparation, during the conduct of the study. Nayana Nagaraj is an employee of Pacira BioSciences, Inc. The authors report no other potential conflicts of interest for this work.