One cadd legacy 1 pump was returned for analysis. The event history log was reviewed and there was no evidence of the reported issue. Three separate delivery accuracy tests were performed and the pump was visually inspected. The reported issue was unable to be confirmed. Delivery accuracy testing found the pumps average delivery error to be within the published specification of +/-6%. However, fluid ingressions were found on the pump by the chassis base of the expulsor, valves and occlusion sensors. The "failed accuracy -9. 65%" issue was possibly caused by fluid ingressions that damaged the gasket. It was recommend that the expulsor assembly be replaced as a preventative measure.
Patient Sequence No: 1, Text Type: N, H10
Information was received indicating that a smiths medical cadd legacy 1 pump failed accuracy by -9. 65% during testing. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5