(b)(4).The sample was received on 2017-01-31 at the maquet (b)(4) site and an investigation was carried out in the complaints laboratory.A quadrox-i adult with reservoir was returned and the reservoir was examined for damage.A broken blood inlet connector was identified, documented and disposed of.A leak test was also performed and a leak at the blood outlet connector was detected and at the connection between the hose and connector.No cracks, holes or other damage were found.The cable binders could be rotated and removed.The impressions of the cable binding bumps are clearly visible on the hose.The probable root cause is thought to be that the cable binding was over-tightened, so that the knobs of the cable tie pushed the tube to one side and displaced it.If the collapsed portion of the tube, which is where the cable lug of the cable tie is, sits on or above the connector¿s mould separation, it can lead to leakage.The dhr review showed no deviations.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and if a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation or action is warranted at this time and the complaint will be closed.Please note this is the final report.
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