This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).One sample was received without the original packaging, in used condition, decontaminated and inside in a plastic bag.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination.Visual inspection did not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.That could cause the failure mode reported.The sample was received without a blue clip and without a white cap.During the functional testing, the sample was fully primed and connected without difficulty, the pump was set running and no alarm was activated.The complaint was not confirmed.The root cause could not be determined due to the complaint not being confirmed.The actions taken were not performed due complaint was not confirmed.
|