Device analysis: one smiths medical cadd administration set was returned for analysis.Visual inspection was performed and indicated that the sample did not contain the blue clip, a small delamination was found at the junction of the pump tube and the spiral tube, no damage or other discrepancies were found.During leak test, the sample returned was tested using the hydrostatic vessel and when the test was performed, a leak was detected at the junction of the spiral tube and the pump tube, thus, the failure mode reported is confirmed, leak detected.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be design.
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