This report has been identified as b.Braun internal report number (b)(4).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 medical internal report number (b)(4).1.General information: complaint: (b)(4) 2.Information to the sample: 2.1 model: infusomat space.2.2 article number: (b)(4).2.3 serial number/batch: (b)(6).2.4 software version: n030005.2.5 hours of operation: 9488.3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.The history files from 2024-01-31 were investigated.A space line was inserted and the infusion started with a rate of 351ml/h and a volume of 500ml.The pre-alarm "vtbi near end" occurred and the infusion was stopped.At this time, 490ml was infused.No other abnormalities were found.3.2 visual inspection: a visual inspection was performed.The cover caps on the screw pillars, and the technician seal (09/2021) on the lower housing were intact and undamaged.The device is in a clean state and no visible damage are to locate.(pictures are attached to the pc notification).3.3 functional inspection: a functional test was performed.The device passes the self-test.A space line was inserted, and the pump identified the line, and it could be selected from the menu.It was possible to put the pump in operation.3.4 pressure inspection: in checking the downstream-sensor the electronic pressure cut-off and the mechanical pressure limitation of the device were tested, according to the requirements of the technical safety check.The electronic pressure cut-off was checked: pressure stage 2: is: 0,25 bar (should be: 0,1-0,7 bar).Pressure stage 9: is: 0,89 bar (should be: 0,8-1,4 bar).The mechanical pressure cut-off was checked: pmax: is: 1,90 bar (should be: 1,8-2,5 bar).Pmin: is: 1,64 bar (should be: >1,5 bar).Safety clamp was checked: pmin: is: 1,83 bar (should be: >1,2 bar).The device matches the required values and standards.All measured values are within our specification.3.5 flow rate inspection: a delivery accuracy measurement according to iec 60601-2-24 was arranged.Here a nominal flow rate of 100 ml/h was chosen.The assessed average deviation "a" of the second operating hour was measured and resulted in a value of +0,27%.((accuracy of set delivery rate should be: ± 5 % according to iec/en 60601-2-24) the device matches the required values and standards.All measured values are within our specification.3.6 disassembling: during the investigation no faults could be detected, to investigate the inside of the device, only the upper housing was removed.No damage or soiling could be found.3.7 test equipment: description: typ nr.: lab.-id.-nr.Sika mh3151 qf04198.3.8 for examination used disposables: description: ref.: lot: infusomat space line , 8700036sp, 24a23e8st1.4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.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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