(b)(4).The device has been requested to send it for investigation to bbm laboratory in (b)(4).In the moment the device is investigate in our service laboratory.If we get new information, an investigation report will create.This report is being filed for pump (b)(4), however there were four (4) other infusion pumps in use on the patient at the time the adverse event occurred.An adverse event report has been filed for each of the pumps in use at the time of the event; the other report numbers are 9610825-2019-00370, 9610825-2019-00372, 9610825-2019-00373, and 9610825-2019-00374.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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(b)(4).(importer) is submitting this report on behalf of b.Braun melsungen ag(manufacturer).This report has been identified as b.Braun melsungen ag internal report (b)(4).During the analysis of the history log files it could be detected that different flow rates were selected (20ml/hr, 50ml/hr and 11 ml/hr).Further it could be detected that no drug on 24th of july was selected.No abnormalities could be found.During the visual inspection of the perfusor space, all cover caps on the screw pillars and the seal on the lower housing were available and undamaged.It was possible to detected some age related sign of wear and tear and a further liquid damage on the viewing window in the operating unit could be detected.The functional test was performed.The device passed the self test with a positive result.A syringe could be successfully identified and selected in the pump menu.It was possible to bring the pump in operation.The delivery accuracy of the pump was checked (rate 5ml/h).The determined value was within specification (+-2%) (according to en iso 60601-2-24).For an inside investigation the device was disassembled.No damages could be found.The complaint could not be confirmed.Summing up all tests, the perfusor space operated within our specification.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)(4).
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