Infusion pump adverse events: experience from medical device reports.
Infusion pumps are used in the hospital setting, nursing home, and increasingly, in the home. Medical Device Reports to the Food and Drug Administration of adverse events during the use of infusion pumps for a 10-year period are described. Examples of cases reported to the Food and Drug Administration are provided. The problems reported by medical facilities (hospitals, medical centers, hospital pharmacies, or nursing homes) are compared with those that occur in the home or reported by home health care agencies. Overall, there were no differences in the types of adverse events reported by medical facilities when compared with reports from home health care agencies. However, there were differences in the location of use of some of the infusion pumps studied, which could reflect the trend toward home care over the past decade.
Brown
S L
SL
Epidemiology Branch, Center for Devices and Radiological Health, Rockville, Maryland, USA.
Morrison
A E
AE
Parmentier
C M
CM
Woo
E K
EK
Vishnuvajjala
R L
RL
D016907:Adverse Drug Reaction Reporting Systems; D002675:Child, Preschool; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007260:Infusion Pumps / Q000009:adverse effects* / Q000145:classification; D014481:United States; D014486:United States Food and Drug Administration