External infusion pumps are medical devices that deliver fluids, including nutrients and medications such as antibiotics, chemotherapy drugs, and pain relievers, into a patient’s body in controlled amounts. Many types of pumps, including large volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral, and insulin pumps, are used worldwide in healthcare facilities such as hospitals, and in the home.
Clinicians and patients rely on pumps for safe and accurate administration of fluids and medications. However, FDA has identified problems that can compromise the safe use of external infusion pumps. These problems can lead to over- or under-infusion, missed treatments, or delayed therapy.
FDA is taking steps to address infusion pump problems through the Infusion Pump Improvement Initiative. (For more information, see the FDA’s White Paper.) FDA is taking actions to improve pump safety, strategies to reduce pump-related risks, and steps you can take to report problems to FDA.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm
FDA Recalls:
11/12/2010 – Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.htm
11/08/2010 – Triton Pole Mount Infusion Pump by WalkMed: Recall – Potential Door Open Alarm Problem: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233014.htm
5/3/2010 – Baxter Colleague Infusion Pumps: FDA Ordering Recall: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210695.htm
