A titan pump, two cylinders and lockout reservoir were received for evaluation.Examination and testing of the returned components revealed a separation through the serialized strain relief tube.Testing revealed this to be a site of leakage.Quality concluded that the rough and irregular surface associated with this separation indicates sufficient stress(s) was exerted to separate the site while in-vivo.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 tubing break 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.(b)(4).
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