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: 28, 2.6 further information: n/a.3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.The last infusion from on (b)(6) 2024 was investigated.A infusion was started with a rate of 186ml/h and a volume of 279ml about 1 hour and 30 minutes.During the infusion, a upstream alarm and a pressure alarm occurred.The reason for the alarm could not be clarified.The pre-alarm "vtbi near end" occurred and a few minutes later the infusion stopped.At this time, 277,61ml 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 production seal on the lower housing were intact and undamaged.The device is in a clean state and no visible damage are to locate.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: 0,40 bar (should be: 0,1-0,7 bar).Pressure stage 9: is: 0,96 bar (should be: 0,8-1,4 bar).The mechanical pressure cut-off was checked: pmax: is: 1,88 bar (should be: 1,8-2,5 bar).Pmin: is: 1,66 bar (should be: >1,5 bar).Safety clamp was checked: pmin: is: 1,79 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 +2,09%.((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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