This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
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This report has been identified as b.Braun melsungen ag internal report # (b)(4).Event 1: we received one used, empty easypump ii lt 270-27-s-eu/sa without packaging and one easypump ii lt 270-27-s-eu/sa in original packaging.The following investigations were conducted: visual inspection: the received samples were taken to a visual inspection according test method for damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G.The impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: weight of the samples were-received condition: sample 1: 71.6 g.Sample 2: 72.6 g.As-received condition the white clamp was closed.The patient connector was open, and the filling port was closed with the closing stoppers discofix.Furthermore, we detected solution at the filling port (lli-cone) and at the patient connector (lla-cone) at the used sample.Damages that would lead to a malfunction were not detected at the received samples.Functional inspection: afterwards the samples were taken to a functional test respectively a leak test was carried out.Therefore, the pumps were approximately filled up to the nominal volume of 270 ml with nacl 0.9 %.After starting the pumps, the pumps worked immediately (solution was running).Leakage was not detected at the received samples.Physical inspection: furthermore, the flow rate of the pumps was tested.Nominal: 10 ml/h.Actual: used sample: 17.2 ml in 1 h; 30.2 ml in 2 hrs; 189.2 in 18 hrs.Sample in original packaging: 18.2 ml in 1 h; 34.3 ml in 2 hrs; 193.7 in 18 hrs.The decisive value to evaluate the flow rate will be measured approx.At the half of the pump running time.The flow rate of the pumps is within the specification.Summary and assessment: a too fast flow of the pumps (as described by the customer) could not be determined.Based on the conducted investigations the tested samples are within the specification.Therefore, the complaint is considered as not confirmed.Device history record (dhr): reviewed the dhr for batch 22g26ged41, there is no such defect detected at in process and at final control inspection pertaining flow rate issue.This report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
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