The returned device was evaluated and there was no evidence of blood on the device.No damages or manufacturing deficiencies were observed during the device inspection that would cause bleeding or bruising at the infusion site.The exposed portion of soft cannula was found to be kinked.It could not be determined when this damage to soft cannula occurred.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.
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