This report has been identified as b.Braun internal report number (b)(4).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.\ 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: n030005.2.5 hours of operation: 2143.2.6 further information: n/a.3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.Due to the lack of a precise error description, the history could not be analyzed extensively.The last infusions were investigated.No anomalies could be detected.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: 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 +0,28%.((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.4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.
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