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: 8713050 2.3 serial number/batch: (b)(6) 2.4 software version: m030003 2.5 hours of operation: 11805 3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.The device history files from 2024-01-06 were investigated.A space line was selected and the infusion started with a rate of 500ml/h and a volume of 1000ml about 2 hours.The infusion was interrupted two times by an pressure alarm.The reason for the pressure alarm could not be clarified.The infusion was continued and at the end of the infusion the pre-alarm "vtbi near and" occurred.The infusion was stopped.At this time, 997,04 ml 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 (353-01-079) 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: 0,44 bar (should be: 0,1-0,7 bar) pressure stage 9: is: 1,08 bar (should be: 0,8-1,4 bar) the mechanical pressure cut-off was checked: pmax: is: 2,21 bar (should be: 1,8-2,5 bar) pmin: is: 1,81 bar (should be: >1,5 bar) safety clamp was checked: pmin: is: 1,95 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 -3,29%.((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: the device was disassembled and the inside was investigated.It could be found liquid residues on the bottom inner frame, the emc protection shield and the lower housing.Also, the safety clips from the bracket were missing.3.7 test equipment: description: typ nr.: lab.-id.-nr.Sika mh3151 qf04198 infusomat space line 8700036sp 23m24e8st5.4.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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