Search

The calibration of the force sensor used to detect occlusions may shift over time. If the force sensor calibration shift is large enough, the pump will display a system failure alarm (including force sensor BGND test, force sensor bridge test, or force…

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product. Specifically, an additional 3 years was added to the expiration date within the udi barcode of the label. The…

Smiths Medical has identified that the Duralife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the Duralife product, the IFU does not provide the cleaning method, duration of autoclave cycle…

There is a potential that Cadd-legacy pumps may not detect that 50 ml and 100 ml Cadd medication cassette reservoirs with flow stop are attached to the pump when the cassettes are properly attached. This issue does not impact 250 ml flow-stop and non-…

Manufacturing variations may cause the green cadd flow stop arm to compress and partially occlude the tubing before clinical use. If this occurs, there is a potential that the occlusion does not resolve when an affected reservoir or administration set is…

Smiths Medical implemented a design change in 2016 to widen the hinge assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added to the H-1000 model. Smiths Medical has become aware that…

Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery…