A pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a rough and irregular separation, indicating sufficient stress(s) had been exerted to separate the site, through the serialized strain relief of the pump.The pump exhaust tubes and inlet tube were overlapping each other while in-vivo.This positioning, in combination with device usage over time, could then cause sufficient stress resulting in the eventual separation of the serialized strain relief of the pump.A separation of this type would then allow the loss of fluid, making the device inoperable.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to crack in tubing by pump are captured in the product risk documentation and are addressed in the literature that accompanies the device.Based on this, no further corrective action is required at this time. see attached letter from fda dated (b)(6) indicating fda has determined coloplast no longer qualifies for participation in the asr exemption #(b)(4) program.Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.
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