(b)(4).We received one used, filled with approx.150 ml easypump ii lt 270-27-s without packaging.The provided sample was subjected to a visual inspection.As-received condition the clamp clip was open and the patient connector was closed with the original wing cap.Damages that would lead to a malfunction were not detected at the sample.Furthermore, we detected crystallized drug residues and solution at the filling port (lli-cone) and we detected solution at the patient connector (lla-cone) of the sample.In addition, the sample was taken to a functional test respectively a leak test was carried out.Therefore the pump was filled up to the nominal volume of 270 ml with nacl 0.9 %.After starting the pump and waiting for 60 minutes the pump did work (solution was running).After these 60 minutes leakages were not detected.The inspected sample is within our specifications.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.All available information has been forwarded to the actual manufacturer.If additional pertinent information becomes available, a follow up report will be filed.
|