The devices was received on (b)(6) 2020 for evaluation.Visual inspection revealed the following: aql-100p sn 1302ce183: the tube set holder is cracked, high vacuum port is damaged, and design foil is peeled.Aql-100cs sn 1607ce0278: the pump tray chipped and bent, 1 wheel missing, 3 wheels corroded.Functional inspection revealed the following: functional inspection indicated the returned device passed all criteria.This included a scale and deficit test with a result of pass.A malfunction could not be determined.Root cause if there is no malfunction, there can be many reasons why the deficit indicated by the pump does not correspond to the expected deficit, including uterine perforation, non-return of irrigation fluid to the waste containers, so the system cannot calculate the deficit (e.G.Fluid remaining on the floor, doctor's clothing or under-buttocks-drape; use of additional suction system with its own collection containers), or wrong manual determination of the deficit.In case of aql-100, an increased deficit can occur if fluid bags are not exchanged in time but are let run dry.In this case, air can enter the tube set and because the roller wheel of the pump keeps turning, the deficit rises.As the returned devices are working according to specification, the most possible root cause is one of the aforementioned device-independent issues.The manufacturer has closed this case.
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