Returned device was received in good physical condition. Evidence of reported problem in event log was found. During the evaluation of the device, the force sensor test error was found at power up and analysts were unable to calibrate the force sensor. There was contamination found inside of the plunger assembly. This was found to be the cause of the issue. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event.
Patient Sequence No: 1, Text Type: N, H10
Information was received indicating that a smiths medical medfusion syringe pump had an issue with a force sensor. The patient was no impacted by the event. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5